The NINDS Human Biospecimen and Data Repository (U24 - Clinical Trial Not Allowed)

The National Institute of Neurological Disorders and Stroke (NINDS), a part of the U.S. Department of Health and Human Services’ National Institutes of Health (NIH), is issuing a Notice of Funding Opportunity (NOFO) inviting applications for organizations to serve as the NINDS Human Biospecimen and Data Repository for Neurological Disorders. This cooperative agreement, structured under activity code U24, aims to sustain and expand the Biospecimen Exchange for Neurological Disorders (BioSEND). Originally established in 2015, BioSEND has distributed over 54,000 biospecimen aliquots globally to researchers and currently houses approximately 450,000 samples across numerous neurological conditions such as Parkinson’s Disease, Huntington’s Disease, and Traumatic Brain Injury. This reissued opportunity under FON RFA-NS-26-010 seeks to maintain the collection and enable its growth to support NINDS’s research priorities. The primary objective of this initiative is to maintain and broaden the scope of a centralized, integrated biobanking infrastructure to foster discovery and validation of biomarkers, and to advance basic, translational, and clinical neurological research. The selected applicant will manage sample collection, processing, storage, and distribution—ensuring availability of high-quality biospecimens (e.g., DNA, RNA, plasma, serum, CSF, urine, saliva, stool, tissue). A critical requirement is providing study design support, training, quality control, and a user-friendly, query-based data interface, facilitating access and linkage of de-identified biospecimens with clinical and phenotypic data. Applicants must propose a robust administrative and operational framework that includes sample tracking, coordination with clinical sites, and integration with other NIH and NINDS-funded data systems. An emphasis is placed on standardizing protocols, ensuring biospecimen integrity, supporting community-based research, and maintaining strict adherence to privacy and ethical standards. Plans must also include disaster recovery and backup systems, and establish a Scientific Advisory Committee to guide repository policy and operation, particularly around sample destruction or usage optimization. Eligible applicants include a broad range of domestic U.S. entities such as public and private higher education institutions, nonprofits, local/state governments, and for-profit organizations including small businesses. Foreign organizations and foreign components are ineligible. All applicants must be registered with federal systems including SAM, Grants.gov, and eRA Commons. Applications must comply fully with NIH submission requirements and be submitted electronically. Applications will be evaluated based on scientific merit, the feasibility of biobanking operations, infrastructure readiness, the applicant team’s qualifications, and proposed innovation in managing biospecimens and facilitating broad access. Milestone-based evaluation will determine continued funding over a five-year maximum project period. NINDS anticipates funding one award, with up to $1.95 million in total costs committed for FY 2026. Budgets are not capped but must be justified relative to project needs. The earliest submission date is February 9, 2026, with a final application due by March 9, 2026, at 5:00 PM local time. Scientific merit reviews are planned for July 2026, with advisory council reviews in October and an anticipated earliest start date of December 2026. This is a reissue of RFA-NS-20-031 and does not allow clinical trials. Contact [email protected] for research inquiries, or [email protected] for financial/grants management questions. More details and updates are available via the official NOFO and the BioSEND website (https://biosend.org/index.html).