Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) Infrastructure Clinical Coordinating Center (CCC) Data Coordinating Center (DCC)

The Network for Excellence in Neuroscience Clinical Trials Infrastructure - Clinical Coordinating Center and Data Coordinating Center opportunity is a forecasted federal cooperative agreement from the Department of Health and Human Services, National Institutes of Health. The opportunity is identified as RFA-NS-28-002 and is associated with Assistance Listing 93.853, Extramural Research Programs in the Neurosciences and Neurological Disorders. The National Institute of Neurological Disorders and Stroke, or NINDS, seeks to continue support for the infrastructure of the Network for Excellence in Neuroscience Clinical Trials, known as NeuroNEXT. The forecast identifies two anticipated awards, although award amounts and total program funding have not yet been provided. NeuroNEXT conducts clinical trials and biomarker validation studies involving neurological disorders in both adult and pediatric populations. The network is intended to provide infrastructure, expertise, and collaborative opportunities that can accelerate innovation and strengthen the development of safe and effective neurotherapeutics. Through high-quality evidence pathways, the program is intended to support research with potential impact for patients with neurological disorders. The forecast specifically anticipates applications for a Clinical Coordinating Center and a Data Coordinating Center to support the NeuroNEXT infrastructure. The funding instrument is a cooperative agreement and the funding activity category is Health. The forecast does not identify an award floor, award ceiling, estimated total program funding, detailed allowable costs, indirect cost limitations, subaward limitations, or other spending restrictions. It explicitly states that cost sharing or matching is not required. Because the opportunity remains in forecast status and applications are not currently being solicited, applicants should not infer additional spending rules or application requirements from this notice. More complete requirements are expected to be available when the formal opportunity is posted. The forecast identifies a broad range of eligible applicants. These include state, county, city or township, and special district governments; federally recognized Native American tribal governments and other Native American tribal organizations; public housing authorities and Indian housing authorities; independent school districts; public and state controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status, other than institutions of higher education; for profit organizations other than small businesses; and small businesses. Additional eligible applicants include eligible agencies of the federal government, U.S. territories or possessions, faith-based or community-based organizations, and regional organizations. No state-specific or sub-state geographic limitation is stated in the forecast. Applications are not being solicited at this time. The forecast is being provided in advance so that potential applicants have sufficient time to develop meaningful collaborations and responsive applications for the anticipated centers. The estimated opportunity posting date is September 1, 2027, and the estimated application due date is November 1, 2027. No letter of intent, concept paper, pre-proposal, notice of intent, or other pre-application gating deadline is identified. The forecast also does not provide application questions, required uploads, review criteria, scoring criteria, or detailed submission mechanics, so those elements cannot yet be specified from the available source. The estimated award date is July 1, 2028, and the estimated project start date is also July 1, 2028, for fiscal year 2028. No project end date or performance period length is stated. The forecast does not state that the opportunity will recur annually, biennially, quarterly, or according to another recurring schedule, so it is treated as nonrecurring based on the currently available information. Questions may be directed to the National Institute of Neurological Disorders and Stroke by email at NEXT1@ninds.nih.gov. No individual grantor contact name or telephone number is provided in the forecast.

Use the forecast period to develop meaningful collaborations and a responsive center application. Align the proposed center with NeuroNEXT's stated role in clinical trials and biomarker validation studies for adult and pediatric neurological disorders and its emphasis on infrastructure, expertise, collaboration, high-quality evidence pathways, and development of safe and effective neurotherapeutics.