Mucosal Immunology Studies Team (MIST) (U01 Clinical Trial Not Allowed)

The U.S. Department of Health and Human Services, through the National Institutes of Health (NIH) and specifically the National Institute of Allergy and Infectious Diseases (NIAID), has reissued its funding opportunity for the Mucosal Immunology Studies Team (MIST) under Funding Opportunity Number RFA-AI-25-018. This program is structured as a U01 Research Project Cooperative Agreement and is designed to support fundamental research into the mechanisms of mucosal immunity across the respiratory, gastrointestinal, and urogenital tracts. Originally launched in 2011 and renewed in 2016 and 2021, the program has advanced the field by supporting dozens of projects, pilot studies, and scientific collaborations. The current announcement continues this long-term effort to improve the understanding of mucosal immune function in health and disease. The purpose of this funding opportunity is to encourage applications from eligible organizations to join MIST, a cooperative research group aimed at generating new discoveries in mucosal immunology. The program seeks to support innovative hypotheses and approaches to understanding immune regulation, barrier function, immune responses to microbial and environmental factors, and the cross-talk between mucosal immunity and other organ systems. Applications are expected to focus on basic mechanisms of mucosal immune function rather than the development of vaccines or therapies. Studies using relevant animal models or human tissues are encouraged if they provide mechanistic insight. Funding is made available through cooperative agreements, which means that NIH program staff will take an active role in guiding, coordinating, and monitoring projects. NIAID intends to commit $3,000,000 in Fiscal Year 2026 to fund four to five awards, which will include $750,000 for an Infrastructure and Opportunities Fund (IOF). Individual project budgets are expected to be no more than $350,000 in direct costs annually, and the maximum project period is five years. The IOF will be administered by one selected awardee institution, under the guidance of a program-wide Steering Committee, to support collaborative, pilot, and translational projects, as well as resource development. Eligibility for this opportunity is broad and includes higher education institutions, nonprofits, for-profit organizations, local governments, tribal governments, state governments, independent school districts, housing authorities, faith-based organizations, regional organizations, and foreign entities. However, NIH recently announced that it will not issue awards to domestic or foreign applicants with foreign subawards or subcontracts. Foreign institutions may apply directly, and foreign components or collaborations without monetary awards are permitted. All applicant institutions must complete standard federal registrations, including SAM.gov, eRA Commons, and Grants.gov. Program Directors/Principal Investigators must hold an eRA Commons ID. Applications must conform to NIH submission rules and use ASSIST, Grants.gov Workspace, or an institutional system-to-system submission pathway. Applications must include an Infrastructure and Opportunities Fund Management Plan, a Data Management and Sharing Plan, and budget allocations for Steering Committee meetings. Noncompliant or incomplete applications will not be reviewed. Applicants must submit electronically by the stated deadlines, and all applications must be received by 5:00 PM local time of the applicant organization. Applications are due on October 21, 2025, with peer review scheduled for March 2026, advisory council review in May 2026, and an earliest start date in July 2026. The expiration date of this announcement is October 22, 2025. Applications will be reviewed for overall impact based on the importance of the research, scientific rigor, feasibility, investigator qualifications, and institutional environment. Reviewers will assess the significance of the research questions, the novelty of approaches, and the quality of design and analysis plans. The IOF management plan will be evaluated for its capacity to coordinate collaborative efforts and ensure effective reporting and fund management. Final funding decisions will consider scientific merit, program priorities, and budget availability. For assistance, applicants may contact Dr. Margaret Morris Fears at NIAID for scientific and research inquiries at maggie.morrisfears@nih.gov or 301-761-5444, and Svetlana Alperovich at NIAID for financial and grants management inquiries at svetlana.alperovich@nih.gov or 301-761-6895. Technical support for electronic submission is available through the eRA Service Desk and Grants.gov. This NOFO continues NIH’s investment in advancing understanding of mucosal immunity and supporting collaborative infrastructure that drives innovation in infectious disease and immunology research.

Follow NIH application guide precisely, include IOF management plan, budget for Steering Committee meetings, comply with new NIH foreign subaward restrictions