NFRP Outreach and Invitation for Response

The Congressionally Directed Medical Research Program (CDMRP) Neurofibromatosis Research Program (NFRP) and the US Army Medical Research Acquisition Activity (USAMRAA) are exploring the possibility of pursuing a Research-based Other Transactions Agreement (rOTA) in accordance with 10 U.S.C. 2371 to support a major goal/product-driven team of exceptional institutions and investigators that will accelerate the clinical translation of basic NF research and ultimately decrease the impact of the disease. The objectives of the resulting rOTA shall be to conceive, design, develop, and conduct collaborative Phase I and II clinical evaluations of promising therapeutic agents for the management or treatment of NF1, NF2, and schwannomatosis. Historically, this requirement has been competed as an assistance agreement, with prior awards made as part of the FY06, FY11, and FY16 portfolios. If the Government pursues this requirement as a rOTA, it is anticipated that this will be awarded as part of the FY21 portfolio. The Government is currently requesting feedback regarding the proposed approach and capabilities. All communication may be sent to Jason.D.Kuhns.civ@mail.mil. This Outreach and Invitation for Response is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding accordingly. General Information The Government anticipates an arrangement with a single Operations Center and a minimum of five Clinical Trial Sites with a demonstrated history of collaborative research. The participants will be jointly responsible for prioritizing, proposing, conducting, and analyzing Phase I and Phase II clinical trials focused on therapeutic interventions for NF1, NF2, and schwannomatosis. The Government is open to discussions regarding teaming arrangements or consortiums. Key Features: Cost Sharing- Research OTA’s require cost sharing, with Government funds not to exceed the total amount provided by other parties to the maximum extent practicable. Any resulting requirement will include a requirement for cost-sharing, and offerors will be required to demonstrate how resources...

All applications are reviewed for technical merit and relevance to the mission of the DHA and its programs. Also, additional specific evaluation criteria will be included in each funding opportunity announcement.

Fiscal year 2017: No Current Data Available. Fiscal year 2018: Gulf War Illness Research Program Fiscal year 2020: Traumatic Brain Injury Research Program Fiscal year 2021: Hearing Restoration Research Program Fiscal year 2022: Combat Readiness-Medical Research Program Fiscal year 2023: Spinal Cord Injury Research Program - Clinical trial, clinical translational research, translational research, and investigator-initiated research projects Fiscal year 2025: Military Burn Research Program - Patient-centered research, technology/therapeutic development, and clinical translational research projects