NFRP Outreach and Invitation for Response

About the Opportunity

The Congressionally Directed Medical Research Program (CDMRP) Neurofibromatosis Research Program (NFRP) and the US Army Medical Research Acquisition Activity (USAMRAA) are exploring a Research-based Other Transactions Agreement (rOTA) under 10 U.S.C. 2371. This initiative aims to support a goal-driven team of institutions and investigators to accelerate the clinical translation of basic neurofibromatosis (NF) research and reduce the disease's impact.

The objectives of the rOTA include conceiving, designing, developing, and conducting collaborative Phase I and II clinical evaluations of promising therapeutic agents for managing or treating NF1, NF2, and schwannomatosis. If pursued, this opportunity will be part of the FY21 portfolio.

This notice is for information and planning purposes only and does not constitute a solicitation. Responses are not offers and will not form a binding contract. All communication may be directed to Jason.D.Kuhns.civ@mail.mil.

Eligibility

Eligible applicants are unrestricted and open to any type of entity, subject to additional clarification in the "Additional Information on Eligibility" section.

Requirements

• Proposals must include a single Operations Center and a minimum of five Clinical Trial Sites with a demonstrated history of collaborative research.
• Participants will jointly prioritize, propose, conduct, and analyze Phase I and II clinical trials focused on therapeutic interventions for NF1, NF2, and schwannomatosis.
• Cost-sharing is required, with Government funds not exceeding the total amount provided by other parties. Offerors must demonstrate how resources (cash and non-cash) will be made available.
• Government funds will not be front-loaded; matching contributions will be required before additional funds are released.
• Proposals may require partnership with a for-profit company, potentially including a letter of commitment.
• Milestone-based payments are anticipated for this project.
• Demonstrated access to patient populations for Phase I and II clinical trials is required.
• The Government intends to negotiate technical and data rights as needed.

The Government is open to discussions regarding teaming arrangements or consortiums.

Additional Information

Assistance Listings: 12.420 -- Military Medical Research and Development

Agency Contact: Jason D. Kuhns, Agreements Officer, 301-619-1861