Centers Without Walls for Collaborative Research in the Epilepsies: Developing Transformative Therapies for Modifying or Preventing Epilepsy (U54) | RFA NS 16 012

Frequently Asked Questions (FAQs)

What is the NIH funding opportunity RFA-NS-16-012 about?

RFA-NS-16-012 is a National Institutes of Health (NIH) funding opportunity to support a single Epilepsy Center without Walls (CWOW) using a U54 cooperative agreement mechanism. The purpose is to fund a tightly coordinated, multi-site research program that operates like one unified center even though investigators may be based at different institutions.

What does "Center without Walls" (CWOW) mean in this opportunity?

In this FOA, a "Center without Walls" refers to a distributed consortium that functions as an integrated center. The emphasis is on strong coordination across multiple sites so the overall program behaves as one cohesive research enterprise rather than separate, loosely connected projects.

How many awards did NIH plan to make under this FOA?

NIH anticipated making one award. The FOA is structured to concentrate resources into a single flagship collaborative center.

What is the maximum award amount listed for this opportunity?

The award ceiling listed is $3,000,000.

What grant mechanism is used and why does it matter?

The opportunity uses a U54 cooperative agreement mechanism. Compared with a standard research grant, a cooperative agreement typically involves substantial NIH program staff involvement, clearer milestones, active oversight, and a strong emphasis on coordination, data sharing, and deliverables intended to accelerate translation.

What is the main scientific focus of the CWOW program?

The scientific focus is collaborative preclinical and clinical research aimed at moving potential therapies into translational and clinical development. The emphasis is on transformative approaches that can modify the course of epilepsy (disease-modifying therapies) or prevent epilepsy from developing (antiepileptogenic or prevention approaches), rather than incremental symptom control.

Is the FOA primarily focused on symptom management therapies?

No. The opportunity is framed around strategies that change the underlying disease trajectory (disease modification) or prevent epilepsy from developing, rather than focusing primarily on incremental symptom control.

What kinds of research activities are expected across preclinical and clinical stages?

The FOA explicitly expects integrated work spanning the pipeline from discovery to clinical readiness. Proposed projects are expected to connect mechanistic and preclinical studies with clinical research components that prepare interventions for human testing.

What are examples of clinical readiness activities mentioned in the FOA?

The FOA highlights activities such as identifying and validating targets, developing and qualifying biomarkers, improving patient stratification, and generating evidence needed to justify and design clinical trials.

Why does the FOA emphasize coordination and integration?

The goal is to reduce friction between discovery and clinical development by running a coordinated, milestone-driven program that links mechanistic studies, preclinical testing, and clinically relevant steps needed to advance candidate interventions toward human trials.

What role do NIH program staff typically play in a U54 cooperative agreement?

The FOA notes that, under a U54 cooperative agreement, NIH program staff typically have substantial involvement compared with a standard research grant. This often includes active project oversight, a milestone-driven approach, and expectations around coordination, data sharing, and concrete deliverables.

Does this opportunity include community partnerships and resource-building?

Yes. Beyond lab and clinic activities, the FOA emphasizes building community partnerships and resources to speed therapy development. This includes creating shared resources that benefit the broader epilepsy community and strengthening relationships with advocacy groups or community organizations.

Why are community partnerships highlighted as important?

The FOA reflects that epilepsy prevention or disease-modification research can depend on patient engagement, access to well-characterized cohorts, longitudinal follow-up, and practical infrastructure for recruitment and retention. Community-facing efforts are intended to support those needs and help move promising interventions into clinical development.

What is the intended role of the CWOW in the broader epilepsy ecosystem?

The CWOW is intended to act as a hub that not only generates research data but also helps reduce barriers in the ecosystem that translates discoveries into therapies, including community-connected infrastructure and shared resources.

Who is eligible to apply as the applicant organization?

Eligibility is broad across many types of U.S.-based organizations. Eligible applicants include various government entities (state, county, city/township, special district), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, federally recognized Native American tribal governments, tribal organizations that are not federally recognized, public housing authorities/Indian housing authorities, nonprofits with or without 501(c)(3) status (other than institutions of higher education), for-profit organizations other than small businesses, small businesses, and other entities.

Are specific institution types explicitly called out as eligible?

Yes. The FOA explicitly calls out categories including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and Indian/Native American tribal governments other than federally recognized ones.

Can a non-U.S. organization apply as the applicant?

No. The FOA states that non-U.S. entities are not eligible to apply as the applicant organization.

Can a non-U.S. component of a U.S. organization apply?

No. The FOA states that non-U.S. components of U.S. organizations are not eligible to apply.

Are foreign components allowed at all?

Yes. The FOA indicates that foreign components, as defined in the NIH Grants Policy Statement, are allowed. This generally means a U.S. applicant may include certain justified international elements within the project under NIH rules, even though the applicant organization itself must be U.S.-based.

What is the Funding Activity Category for this opportunity?

The Funding Activity Category is Health.

What CFDA number is associated with this FOA?

The opportunity is associated with CFDA number 93.853.

When was this FOA created and when did it close?

The FOA was created on September 24, 2015, and the original closing date was March 8, 2016.

Is this FOA currently open for applications?

The listing reflects a historical competition rather than an open call today, based on the provided creation and closing dates.

What is the overall goal of concentrating funding into a single center?

The FOA is designed to concentrate resources into one highly coordinated, milestone-driven consortium that unifies preclinical and clinical expertise, builds community-connected infrastructure, and accelerates progress toward therapies that can prevent epilepsy or fundamentally change its course.