The Department of the Army, through the US Army Medical Research Acquisition Activity (USAMRAA), is forecasting an opportunity for a Research-based Other Transactions Agreement (rOTA) under the Neurofibromatosis Research Program (NFRP). This initiative aims to accelerate the clinical translation of basic research related to neurofibromatosis (NF) by conducting collaborative Phase I and II clinical trials focused on promising therapeutic agents for NF1, NF2, and schwannomatosis. Historically, this requirement has been addressed through assistance agreements, and the government is now seeking feedback on this proposed approach, emphasizing the need for cost-sharing arrangements and access to patient populations. Interested parties can reach out to Jason D. Kuhns at jason.d.kuhns.civ@mail.mil for further information, as this outreach is for planning purposes and does not constitute a solicitation.

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&#8217;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 (e.g. cash and non-cash) will be made available for this project. Please also note that the Government&#8217;s funds shall not be front-loaded, with certain matches being required before additional Government funds are made available. Industry Partner- Any resulting proposal request may include a requirement to partner with a for-profit company. A letter of commitment may be required as part of any resulting proposal. Milestone Based Payments- It is anticipated that milestone based payments will be included in this project. Technical/ Data Rights- The Government intends to negotiate technical/ data rights as needed. Access to populations- Given that this rOTA will sponsor Phase I and II clinical trials, any resulting proposal will include demonstrated access to patient populations.

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