Opportunity Information: Apply for W81XWH 20 RTRP CNA
The DoD Reconstructive Transplant, Clinical Network Award (RTRP CNA; Funding Opportunity Number W81XWH-20-RTRP-CNA) is a Department of Defense funding opportunity run through the U.S. Army Medical Research Acquisition Activity (USAMRAA) under the Reconstructive Transplant Research Program (RTRP). Its core purpose is to build a large, multi-institutional clinical network focused on vascularized composite allotransplantation (VCA), specifically face and hand transplantation. The program is trying to move these procedures closer to routine clinical care by doing something the field has struggled with: aligning major VCA centers around shared, standardized clinical protocols and standard operating procedures (SOPs), then testing those agreed-upon approaches in coordinated, multi-site clinical trials. The underlying rationale is that broad consensus and multi-center evidence are essential steps for shifting face and hand transplantation away from being treated as purely experimental and toward being considered a viable option that could ultimately support payer and insurance reimbursement.
The award is structured as a single, two-phase effort centered on one funded entity: the Clinical Network Coordinating Center. Rather than funding many separate stand-alone projects, DoD intends to fund one Coordinating Center that becomes the operational hub for the entire Clinical Network. This hub is expected to handle the day-to-day backbone work that makes a multi-institutional program function: administrative coordination, operational support, data management, and overall execution so Network activities move on schedule. Strategic guidance and oversight come from the RTRP Clinical Network Steering Committee, which includes the RTRP Programmatic Panel, program staff, and other key USAMRDC personnel. In practice, the Coordinating Center runs the network, but it does so under Steering Committee direction, with major decisions and progression through phases tied to that oversight.
Phase I lasts up to 2 years and is essentially the build-and-launch stage. It has five main objectives. First, the Coordinating Center must establish the Clinical Network by working with the Steering Committee to invite VCA Centers and other necessary collaborators to participate as Network Sites via subawards. An important detail is that the Network Sites are not included in the initial application itself; the Coordinating Center is selected first, and then the broader network membership is built after award. The network is expected to include as many face and hand VCA centers as possible and to bring in additional collaborators as needed so the network collectively covers the expertise required across RTRP focus areas. Second, the network must develop standardized protocols and SOPs for both face and hand transplantation. The Coordinating Center is responsible for setting up the structure and collaborative environment that allows participating sites to work as equal partners toward harmonized, consensus-driven clinical procedures. Third, the Coordinating Center and Network Sites must produce two full clinical trial applications: one for face transplantation and one for hand transplantation, each grounded in the standardized protocols and SOPs developed by the network. Fourth, the Coordinating Center must arrange and pay for an external scientific peer review of both trial applications, then submit those peer review results to the Steering Committee for assessment. Fifth, Phase I must secure required regulatory approvals, including any approvals needed from the U.S. Food and Drug Administration (FDA). After the Steering Committee authorizes moving forward, the standardized protocols and SOPs and the reviewed trial plans must go to a single unified Institutional Review Board (IRB) of record, and then to the USAMRDC Human Research Protection Office (HRPO) for final human-subjects protections review and approval.
Funding for Phase I is capped at $3 million in total costs to the Coordinating Center over the 2-year period of performance. The Coordinating Center is also expected to manage funds flowing to Network Sites through subawards and to support other key collaborators as necessary, meaning the award is not just paying for the lead organization but for the coordination and resourcing of the full network it assembles. Phase II is an option period, not guaranteed, and depends on both successful completion of Phase I objectives and the availability of funds. The single Phase II objective is to conduct the clinical trials: one multi-institutional face transplantation trial and one multi-institutional hand transplantation trial designed to assess and validate the standardized protocols and SOPs created in Phase I. Participating VCA Network Sites will serve as enrollment sites for one or both trials depending on whether they specialize in face transplantation, hand transplantation, or both.
From an applicant and administrative standpoint, the opportunity was categorized as discretionary funding, with funding instruments listed as cooperative agreement and grant, reflecting DoD’s expectation of substantial programmatic involvement and coordinated execution rather than an arms-length research award. Eligibility was described as unrestricted (open to any entity type, subject to any additional eligibility text). Only one award was expected, reinforcing that DoD wanted a single Coordinating Center to unify and drive the field toward consensus standards and produce multi-site clinical evidence. The original posting timeline shows a creation date of September 25, 2020, and an original closing date of December 3, 2020, and it is listed under CFDA 12.420 (military medical research and development).Apply for W81XWH 20 RTRP CNA
- The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Reconstructive Transplant, Clinical Network Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
- This funding opportunity was created on Sep 25, 2020.
- Applicants must submit their applications by Dec 03, 2020. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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FAQs: DoD Reconstructive Transplant, Clinical Network Award (RTRP CNA)
What is the DoD Reconstructive Transplant, Clinical Network Award (RTRP CNA)?
The RTRP Clinical Network Award (Funding Opportunity Number W81XWH-20-RTRP-CNA) is a Department of Defense funding opportunity administered through the U.S. Army Medical Research Acquisition Activity (USAMRAA) under the Reconstructive Transplant Research Program (RTRP). It is designed to build and operate a large, multi-institutional clinical network focused on vascularized composite allotransplantation (VCA), specifically face and hand transplantation.
What is the main purpose of this award?
The core purpose is to align major VCA centers around shared, standardized clinical protocols and standard operating procedures (SOPs), and then evaluate those agreed-upon approaches through coordinated, multi-site clinical trials. The program aims to help move face and hand transplantation closer to routine clinical care by generating broad consensus and multi-center evidence.
Which medical procedures and clinical areas are in scope?
The opportunity is focused on vascularized composite allotransplantation (VCA), specifically face transplantation and hand transplantation.
Why is the DoD emphasizing standardized protocols and SOPs?
According to the opportunity description, the field has struggled to align major centers around shared, standardized approaches. The DoD is targeting consensus-driven protocols and SOPs because broad agreement and multi-center evidence are described as essential steps toward shifting face and hand transplantation away from being treated as purely experimental.
How is this award structured?
The award is structured as a single, two-phase effort centered on one funded entity: the Clinical Network Coordinating Center. Rather than funding multiple stand-alone projects, DoD intends to fund one Coordinating Center that serves as the operational hub for the entire Clinical Network.
How many awards were expected?
Only one award was expected. The intent was to fund a single Coordinating Center to unify network operations and drive standardization and coordinated clinical evidence generation.
What is the Clinical Network Coordinating Center?
The Clinical Network Coordinating Center is the single funded hub responsible for the administrative coordination, operational support, data management, and overall execution needed to keep network activities moving on schedule.
Does the Coordinating Center operate independently?
The Coordinating Center is expected to run day-to-day network operations, but strategic guidance and oversight are provided by the RTRP Clinical Network Steering Committee. Major decisions and progression through phases are tied to that oversight.
Who provides oversight and strategic direction?
Oversight and strategic guidance come from the RTRP Clinical Network Steering Committee, which includes the RTRP Programmatic Panel, program staff, and other key U.S. Army Medical Research and Development Command (USAMRDC) personnel.
What happens in Phase I?
Phase I lasts up to 2 years and is the build-and-launch stage. It includes five main objectives: (1) establish the Clinical Network and invite VCA Centers and other collaborators as Network Sites via subawards; (2) develop standardized protocols and SOPs for face and hand transplantation; (3) produce two clinical trial applications (one face, one hand) grounded in the standardized protocols and SOPs; (4) arrange and pay for an external scientific peer review of both trial applications and submit the results to the Steering Committee; and (5) secure required regulatory approvals, including any FDA approvals needed, followed by review through a single unified IRB of record and then USAMRDC HRPO for final human-subjects protections approval.
Are Network Sites included in the initial application?
No. The opportunity specifies that Network Sites are not included in the initial application. The Coordinating Center is selected first, and then the broader network membership is built after award through invitations and subawards.
What kinds of organizations are expected to become Network Sites?
The network is expected to include as many face and hand VCA centers as possible and also to include additional collaborators as needed so the network covers the expertise required across RTRP focus areas.
What are the required clinical trial deliverables in Phase I?
Phase I requires two full clinical trial applications: one for a face transplantation trial and one for a hand transplantation trial. Each must be grounded in the standardized protocols and SOPs developed by the network.
What is required regarding peer review of the trial applications?
The Coordinating Center must arrange and pay for an external scientific peer review of both clinical trial applications and then submit the peer review results to the Steering Committee for assessment.
What regulatory and ethics reviews are required before trials can begin?
Phase I must secure required regulatory approvals, including any approvals needed from the U.S. Food and Drug Administration (FDA). After Steering Committee authorization, the standardized protocols, SOPs, and reviewed trial plans must go to a single unified Institutional Review Board (IRB) of record and then to the USAMRDC Human Research Protection Office (HRPO) for final review and approval related to human-subjects protections.
How long is Phase I and what is the funding cap?
Phase I lasts up to 2 years. Funding for Phase I is capped at $3 million in total costs to the Coordinating Center over the 2-year period of performance.
Does the Phase I funding only support the lead organization?
No. The Coordinating Center is expected to manage funds flowing to Network Sites through subawards and support other key collaborators as necessary. The award supports both the lead organization and the coordinated network it assembles.
What is Phase II?
Phase II is an option period (not guaranteed). It depends on successful completion of Phase I objectives and the availability of funds.
What is the objective of Phase II?
The single Phase II objective is to conduct two multi-institutional clinical trials: one face transplantation trial and one hand transplantation trial, designed to assess and validate the standardized protocols and SOPs created in Phase I.
How do Network Sites participate in Phase II trials?
Participating VCA Network Sites serve as enrollment sites for one or both trials depending on whether they specialize in face transplantation, hand transplantation, or both.
What type of funding instrument is used for this opportunity?
The opportunity lists funding instruments as a cooperative agreement and a grant, reflecting DoD expectations of substantial programmatic involvement and coordinated execution rather than an arms-length research award.
Is this opportunity discretionary or entitlement-based?
It was categorized as discretionary funding.
Who was eligible to apply?
Eligibility was described as unrestricted, meaning it was open to any entity type, subject to any additional eligibility text (as noted in the opportunity description).
What is the relationship between this effort and insurance reimbursement?
The opportunity rationale states that broad consensus and multi-center evidence are essential steps toward moving face and hand transplantation away from being considered purely experimental and toward becoming a viable option that could ultimately support payer and insurance reimbursement.
Which agency administers the opportunity and under what program?
The opportunity is run through USAMRAA under the DoD Reconstructive Transplant Research Program (RTRP).
What is the CFDA listing associated with this opportunity?
The opportunity is listed under CFDA 12.420 (military medical research and development).
What were the original posting dates for this opportunity?
The original posting timeline shows a creation date of September 25, 2020, and an original closing date of December 3, 2020.
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