Opportunity Information: Apply for RFA NS 16 023

  • The HHS-NIH11 in the health sector is offering a public funding opportunity titled "Center without Walls for the Identification and Validation of Molecular Mechanisms Contributing to Tau Pathogenesis and Associated Neurodegeneration in Frontotemporal Degeneration (FTD) (U54)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853, 93.866,.
  • This funding opportunity was created on Feb 24, 2016 and posted on Feb 24, 2016.
  • Applicants must submit their applications by May 10, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Each selected applicant is eligible to receive up to $1,500,000.00 in funding.
  • The number of recipients for this funding is limited to 2 candidate(s).
  • Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
Apply for RFA NS 16 023

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Opportunity Summary:

The grant opportunity "Center without Walls for the Identification and Validation of Molecular Mechanisms Contributing to Tau Pathogenesis and Associated Neurodegeneration in Frontotemporal Degeneration (FTD) (U54)" (Funding Opportunity Number RFA-NS-16-023) is a cooperative agreement from the NIH (HHS-NIH11) focused on accelerating progress in understanding and validating the biological mechanisms that drive tau-related toxicity in Frontotemporal Degeneration. The central goal is to bring together multiple institutions and disciplines in a single coordinated, milestone-driven center so the team can move beyond isolated findings and instead generate converging, human-relevant evidence for mechanisms that could realistically support therapeutic target validation. While the scientific emphasis is on tau pathogenesis and neurodegeneration in FTD, the FOA is also designed to produce practical outputs, such as tools and resources that can be used to evaluate targets in future (or ongoing) FTD clinical trials.

A key feature is the "Center without Walls" model, which implies a distributed research center rather than a single-site institute. The FOA is deliberately structured to require collaboration across projects and cores in a way that makes the whole center more powerful than the sum of its parts. Applicants have to demonstrate real synergy: the research aims must be interdependent, and reviewers are meant to see that the objectives would not be achievable without the shared infrastructure, coordinated decision-making, and integrated data and resource pipelines that the center provides. This is not meant to be a collection of loosely related projects; it is intended to function like a unified program with shared priorities, aligned timelines, and coordinated deliverables.

The application must be built around several mandatory components. First, it must include an Administrative Core to handle leadership, communications, budgeting, compliance, and overall center coordination. Alongside that, a Scientific Governance Structure is required, meaning a formal plan for decision-making, project oversight, conflict resolution, prioritization of experiments, and ongoing evaluation of progress. The center also must propose at least three distinct Research Projects, each with clear milestone plans. Those milestones are important because they make the work measurable and help NIH staff manage the cooperative agreement structure, where the funder typically has more involvement than in a standard grant. In practice, this pushes applicants to define concrete go/no-go criteria, timelines, and outputs rather than offering only broad exploratory aims.

In addition to the research projects, the FOA requires multiple cores that support center-wide functioning and ensure the work produces reusable, community-facing value. At least one Resource Core must be included, and it must support the basic research efforts of at least two of the proposed research projects, ensuring shared platforms rather than project-specific services. A Data Coordination Core is also required, with an explicit responsibility to facilitate distribution of data generated by the center to the broader research community. This signals a strong expectation that datasets, methods, and potentially other outputs will be organized, curated, and shared in a timely and usable way, not left siloed within the participating institutions. Finally, the center must include a Human Biology Validation Core, which is intended to strengthen the link between mechanistic discoveries and human disease relevance. This core is meant to validate mechanisms identified through the center and to validate resources or tools developed under the program, emphasizing translational credibility and reducing the risk that promising findings are limited to non-human or overly artificial systems.

From an administrative standpoint, this is a discretionary funding opportunity using the cooperative agreement mechanism (U54), under the health activity category. The FOA lists CFDA numbers 93.853 and 93.866, and it anticipates making about two awards. The award ceiling is $1,500,000, reflecting the center-scale scope and infrastructure requirements. Eligibility is broad and includes many types of applicants: various levels of government entities, public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, tribal governments and tribal organizations, and other entities as described in the full eligibility text.

The opportunity was posted and created on February 24, 2016, with an application closing date of May 10, 2016. Strategically, it is positioned as part of the NIH response to the Alzheimers Disease Related Dementias (ADRD) challenges described in the 2015 update to the National Plan to Address Alzheimers Disease. Even though FTD is distinct from Alzheimer disease, tau biology and related neurodegenerative mechanisms overlap across dementias, and the FOA is clearly meant to push the field toward mechanism-based, human-relevant target validation that can feed therapeutic development pipelines. In short, NIH is using this U54 center framework to force tight coordination across institutions, require rigorous milestones, and ensure that the outputs (validated mechanisms, data, and tools) are broadly useful to the community and directly supportive of clinical translation in FTD.

Frequently Asked Questions (FAQs)

What is the title of this grant opportunity?

The opportunity is titled "Center without Walls for the Identification and Validation of Molecular Mechanisms Contributing to Tau Pathogenesis and Associated Neurodegeneration in Frontotemporal Degeneration (FTD) (U54)."

What is the Funding Opportunity Number (FON)?

The Funding Opportunity Number is RFA-NS-16-023.

Which agency is offering this funding opportunity?

This is a National Institutes of Health (NIH) opportunity listed under HHS-NIH11.

What type of funding mechanism is used?

The mechanism is a cooperative agreement (U54). This structure typically involves substantial NIH involvement compared to standard grant mechanisms, and the FOA emphasizes milestone-driven management aligned with that cooperative model.

What is the overall purpose of the FOA?

The FOA is designed to accelerate progress in understanding and validating the biological mechanisms that drive tau-related toxicity in Frontotemporal Degeneration (FTD), with an emphasis on generating converging, human-relevant evidence that can support therapeutic target validation.

What scientific area is the FOA focused on?

The scientific emphasis is on tau pathogenesis and associated neurodegeneration in Frontotemporal Degeneration (FTD), specifically the identification and validation of molecular mechanisms contributing to tau-related toxicity.

How is this FOA intended to support therapeutic development?

Beyond producing mechanistic findings, the FOA is intended to generate practical outputs such as tools and resources that can be used to evaluate therapeutic targets in future or ongoing FTD clinical trials, strengthening the connection between basic discovery and clinical translation.

What does "Center without Walls" mean in this context?

"Center without Walls" indicates a distributed, multi-institutional research center model rather than a single-site institute. The program is meant to function as a unified center across participating institutions with shared priorities, aligned timelines, coordinated deliverables, and integrated pipelines.

What kind of collaboration does the FOA require?

The FOA requires genuine synergy across projects and cores. The research aims are expected to be interdependent, with shared infrastructure and coordinated decision-making. Reviewers are expected to see that the objectives could not be achieved by loosely connected projects operating independently.

Is this meant to be a collection of separate projects?

No. The FOA explicitly signals that it is not intended to support a set of loosely related projects. It is intended to operate like a unified program with coordinated priorities, shared infrastructure, integrated data and resource pipelines, and milestone-driven deliverables.

What are the required components of an application?

The FOA requires several mandatory components, including:

  • An Administrative Core
  • A Scientific Governance Structure
  • At least three distinct Research Projects (each with clear milestone plans)
  • At least one Resource Core (supporting at least two research projects)
  • A Data Coordination Core
  • A Human Biology Validation Core

What is the role of the Administrative Core?

The Administrative Core is responsible for leadership and overall center coordination, including communications, budgeting, compliance, and related administrative functions needed to run a multi-institutional center.

What is meant by a required Scientific Governance Structure?

The FOA requires a formal plan for how the center will make decisions and manage itself, including project oversight, conflict resolution, prioritization of experiments, and ongoing evaluation of progress.

How many Research Projects are required?

The application must propose at least three distinct Research Projects.

Why are milestones emphasized in this FOA?

Milestones are central because they make progress measurable and support the cooperative agreement model. The FOA pushes applicants to define concrete timelines, outputs, and go/no-go criteria rather than relying on broad or purely exploratory aims.

What is required for the Resource Core?

At least one Resource Core must be included, and it must support the basic research efforts of at least two of the proposed research projects. This reflects an expectation of shared platforms and center-wide utility rather than project-specific services.

What is the purpose of the Data Coordination Core?

The Data Coordination Core is required and must facilitate distribution of data generated by the center to the broader research community. This indicates an expectation that datasets and related outputs will be organized, curated, and shared in a timely and usable way.

Does the FOA expect data and outputs to be shared beyond the participating institutions?

Yes. The FOA explicitly assigns the Data Coordination Core responsibility for facilitating distribution of center-generated data to the broader research community, signaling an emphasis on community-facing access rather than keeping outputs siloed.

What is the Human Biology Validation Core and why is it required?

The Human Biology Validation Core is required to strengthen the link between mechanistic discoveries and human disease relevance. Its purpose is to validate mechanisms identified through the center and to validate resources or tools developed under the program, supporting translational credibility and reducing reliance on non-human or overly artificial systems alone.

What is the activity category for this opportunity?

The FOA is listed under the health activity category.

What are the CFDA numbers associated with this FOA?

The FOA lists CFDA numbers 93.853 and 93.866.

How many awards does NIH anticipate making?

The FOA anticipates making about two awards.

What is the maximum award amount (ceiling)?

The award ceiling is $1,500,000.

Who is eligible to apply?

Eligibility is broad and includes multiple organization types, including:

  • Various levels of government entities
  • Public and private institutions of higher education
  • Nonprofit organizations (with or without 501(c)(3) status)
  • For-profit organizations (other than small businesses)
  • Small businesses
  • Tribal governments and tribal organizations
  • Other entities as described in the full eligibility text

When was this opportunity posted?

The opportunity was posted and created on February 24, 2016.

What was the application closing date?

The application closing date was May 10, 2016.

How does this FOA relate to broader NIH and national strategy efforts?

The FOA is positioned as part of the NIH response to the Alzheimers Disease Related Dementias (ADRD) challenges described in the 2015 update to the National Plan to Address Alzheimers Disease.

Why is FTD included in an ADRD-related strategy?

Although Frontotemporal Degeneration is distinct from Alzheimer disease, the FOA notes that tau biology and related neurodegenerative mechanisms overlap across dementias, supporting a strategy that advances mechanism-based, human-relevant target validation with broader relevance.

What are the expected kinds of outputs from this center?

Based on the FOA description, expected outputs include validated molecular mechanisms linked to tau pathogenesis in FTD, along with practical tools, resources, and well-curated datasets that are organized for reuse and dissemination to support future or ongoing clinical translation efforts.

What is the main difference between this U54 center and typical investigator-initiated projects?

This FOA emphasizes an integrated center model with mandatory cores, a required governance structure, and milestone-driven, measurable deliverables across multiple interdependent projects, with stronger NIH involvement consistent with a cooperative agreement.

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