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DoD Neurofibromatosis Clinical Consortium Award (FY16 NFRP CCA) - FAQs

What is the DoD Neurofibromatosis Clinical Consortium Award (FY16 NFRP CCA)?

The FY16 NFRP CCA is a Department of Defense-funded grant/cooperative agreement opportunity designed to build and operate a highly coordinated clinical research consortium focused on neurofibromatosis (NF). Its purpose is to create a centralized, ready-to-run platform for early-phase clinical trials rather than funding isolated, stand-alone projects.

What is the main goal of this award?

The central goal is to speed the clinical translation of strong basic and preclinical NF research into patient-facing clinical studies, with the long-term aim of reducing disease burden across NF1, NF2, and schwannomatosis. The program is structured to move promising therapeutic agents into early-stage clinical testing efficiently and consistently across multiple institutions.

What diseases or conditions does the consortium focus on?

The consortium is focused on neurofibromatosis, specifically NF1, NF2, and schwannomatosis.

What types of studies are supported under this mechanism?

The award supports the conception, design, development, and execution of collaborative Phase I and Phase II clinical evaluations of candidate therapies intended to manage or treat NF1, NF2, and schwannomatosis.

Is this funding intended for a single research project or a network?

It is intended for a coordinated network. The mechanism is designed to support a consortium that can run multiple early-phase clinical trials through shared planning, shared infrastructure, and joint decision-making across multiple institutions.

How is this consortium expected to speed up clinical trials?

The consortium is expected to enable rapid execution of early-phase trials by using a centralized structure and shared operational capabilities. This reduces the need to rebuild administrative and operational frameworks for each new therapeutic opportunity and supports consistent trial implementation across sites.

What is the required consortium structure?

Applicants must propose a single Operations Center plus at least five Clinical Trial Sites. The participating sites must also demonstrate a history of collaborative research to show the network can function as an integrated working team.

What is the role of the Operations Center?

The Operations Center leads the consortium and submits one unified application on behalf of the entire network. It is responsible for central coordination and is the single entity that receives the award.

Can the Operations Center also be a Clinical Trial Site?

Yes. The Operations Center may serve as one of the Clinical Trial Sites if it has the appropriate capabilities and patient access.

How many awards will be made under this opportunity?

Only one award is anticipated. The intent is to create a single, unified NF clinical trials consortium rather than multiple competing networks.

Who actually receives the award funds?

The award is made to the Operations Center. While multiple institutions participate in the consortium, the Operations Center is the sole award recipient and is expected to distribute funding to participating Clinical Trial Sites through subawards, subcontracts, or other funding instruments.

How will Clinical Trial Sites be supported financially?

Funding is intended to flow through the Operations Center to support both central coordinating responsibilities and trial execution activities at the Clinical Trial Sites. This includes support for protocol activities, recruitment, data collection, and other trial-related functions conducted at the sites.

What does it mean that this opportunity is a cooperative agreement and grant?

The listing indicates the mechanism is a cooperative agreement and grant, and applicants should expect substantial coordination and oversight expectations typical of cooperative clinical research programs.

What will reviewers focus on when evaluating applications?

Applications are evaluated largely on the consortium's ability to deliver early-phase NF clinical trials. Reviewers will focus on the initial clinical trials proposed, the capabilities and resources to carry them out, the organizational plan for day-to-day consortium operations, and the overall feasibility of achieving the award goals.

Are applicants required to propose clinical trials in the application?

Yes. The evaluation emphasizes the initial clinical trials proposed for implementation, and the option periods described in the application must each include at least one clinical trial.

Is the consortium expected to run only the initial set of trials?

No. A key expectation is that the consortium will continue to collaborate during the performance period to identify and advance additional trials for implementation, functioning as an ongoing clinical testing engine rather than a one-off trial award.

How much total funding is available?

The funding plan describes up to $9 million total in support of the consortium: $5 million in initial funding plus two additional option periods of $2 million each.

How is the initial funding structured?

Initial funding is $5 million using FY16 NFRP Congressional appropriations.

What are the option periods, and are they guaranteed?

The solicitation includes two option periods that must be described in the application. Each option period is planned at $2 million and must propose at least one clinical trial. These options are contingent on future Congressional appropriations, so they are not guaranteed.

Who manages this funding opportunity?

This is a discretionary DoD opportunity managed by DOD-AMRAA.

What is the Funding Opportunity Number (FON)?

The Funding Opportunity Number is W81XWH-16-NFRP-CCA.

What CFDA number is associated with this opportunity?

The opportunity is associated with CFDA 12.420.

Who is eligible to apply?

Eligibility is described as unrestricted, meaning the opportunity is open to a broad range of entity types as allowed by the full announcement details.

When was the opportunity posted?

The opportunity was posted on May 6, 2016.

What is the application deadline (closing date)?

The original and current closing date listed is August 1, 2016.

What makes this award different from typical clinical trial funding?

Rather than supporting isolated trials or single-institution projects, this mechanism is designed to fund a centralized consortium with shared infrastructure, coordinated prioritization of candidate therapies, and consistent multi-site trial execution, so new NF therapeutic opportunities can be evaluated more efficiently over time.