The RTRP Clinical Network Award mechanism was first offered in FY20, with awards to be made as grants or cooperative agreements. Three applications were received, but none were funded. This FY22 research announcement is being offered through a different type of award mechanism, a Research Other Transaction Award (rOTA) under the authority of 10 USC 4021.
Statement on the Research Other Transaction Agreement: The principal purpose of a rOTA is to carry out non-duplicative basic, applied, and advanced research projects rather than the acquisition of property or services for the direct benefit or use of the government. The anticipated deliverables to the government under a rOTA are reports on research rather than prototypes.
The rOTA requires resource sharing, with government funds not to exceed the total amount provided by other parties to the maximum extent practicable. Offerors will be required to demonstrate how resources (e.g., cash and non-cash) will be made available for this project. The rOTA is intended to promote the use of best business practices and to foster relationships among performers from different sectors.
In addition, as a matter of DOD policy, rOTAs may only be awarded when one or more forprofit firms are to be involved either in the: (1) performance of the research project(s) or (2) commercial application of the research results. A consortium should either include, collaborate with, or involve one or more for-profit firms (e.g., pharmaceutical company to provide medication, rehabilitation clinic to provide services to recipients, etc.) in addition to state or local government agencies, institutions of higher education, or other nonprofit organizations. For the FY22 Clinical Network Award, the for-profit firm may be involved in either Phase 1, Phase 2, or both phases of the award.
Deadlines:
• Required Pre-Application Deadline: Jan. 18, 2023
• Application Submission Deadline: TBA
To meet the intent of the FY22 RTRP Clinical Network Award mechanism, applicants must address the standardization and assessment of protocols and/or clinical practice guidelines (CPGs) for all the following Focus Areas for both 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)
The Network Director at the Coordinating Center must be an independent investigator at or above the level of Associate Professor (or equivalent) with experience in developing and running large-scale initiatives such as clinical trials or consortia. Each investigator may be named on only one FY22 RTRP Clinical Network Award application as the PI/Network Director.
Resource sharing/matching is a requirement, with government resources not to exceed the total amount provided by other parties to the maximum extent practicable.
See solicitaiton for details