The NINDS Human Cell and Data Repository (U24 - Clinical Trial Not Allowed) | RFA NS 24 040

Opportunity Information: Apply for RFA NS 24 040

The funding opportunity titled "The NINDS Human Cell and Data Repository (U24 - Clinical Trial Not Allowed)" (RFA-NS-24-040) is a National Institutes of Health (NIH) Notice of Funding Opportunity from the National Institute of Neurological Disorders and Stroke (NINDS). It is a reissue of an earlier announcement (RFA-NS-19-038) and uses the U24 cooperative agreement mechanism, which means the award is intended to support a resource or infrastructure effort where NIH program staff typically have substantial involvement during the project period. The overall purpose is to sustain and further develop a national repository that makes high-quality human cell resources and associated data broadly available to the research community to accelerate basic and translational studies in neurological disorders. Clinical trials are not allowed under this NOFO, keeping the focus on repository operations, resource generation, quality systems, and distribution rather than testing interventions in human participants.

At the core of the project is the NINDS Human Cell and Data Repository (NHCDR), which is expected to maintain and manage an existing collection of human fibroblast lines and induced pluripotent stem cell (iPSC) lines. Beyond simply storing materials, the repository is intended to actively develop the collection by generating new lines that align with the NINDS mission, expanding source cells and iPSCs, and performing rigorous characterization so that researchers can rely on consistent identity, quality, and usability. Where it makes scientific sense, the repository may also genetically modify iPSC lines to create new, high-quality resources (for example, to introduce or correct variants, create isogenic controls, or engineer reporter lines), as long as these activities support the mission of enabling neurological disease research and are conducted under appropriate ethical, regulatory, and quality frameworks.

A major emphasis is broad distribution and access. The NHCDR is meant to serve as a national resource that provides human cell materials and related datasets to qualified users in both academia and industry. That distribution role implies the awardee will need strong operational capabilities: intake and tracking of biospecimens and derived lines, standardized processing workflows, documentation and data management, quality control and assurance, inventory systems, request and review procedures for distributing materials, and reliable fulfillment logistics. Just as important, the "data repository" aspect indicates that the resource is not only physical cell lines but also the associated metadata and characterization information that make those lines valuable and interpretable to downstream researchers.

The opportunity sits within the health funding activity category and is associated with CFDA number 93.853. The application due date listed is 2024-10-17 (original closing date), and the announcement was created on 2024-06-24. While an award ceiling and expected number of awards are not specified in the provided source text, applicants should generally interpret U24 cooperative agreements as substantial, multi-component efforts that require clear plans for governance, performance metrics, user support, and long-term sustainability consistent with NIH expectations for national research resources.

Eligibility is broad across U.S.-based organizations and government entities. Eligible applicants include state, county, and city governments; special district governments; 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; and small businesses. The NOFO also highlights additional eligible categories such as 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), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, there are clear restrictions related to foreign involvement: non-domestic (non-U.S.) entities are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as NIH defines them) are not allowed. In practical terms, this confines the applicant organization and project activities to allowable U.S. settings and prevents structuring the work to include foreign components under NIH policy.

In summary, this NOFO is essentially asking for an organization capable of running a high-functioning, national-scale human cell and data repository focused on neurological disorders. The award supports maintaining and growing an existing collection of fibroblast and iPSC lines, producing and characterizing additional high-quality iPSC resources (including genetic modifications when appropriate), and distributing these materials and their associated data widely to qualified academic and industry investigators. The cooperative agreement structure underscores that NIH expects active coordination and oversight to ensure the repository meets community needs, adheres to strong standards for quality and documentation, and serves as a reliable backbone resource for neurological disease research rather than a clinical testing program.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "The NINDS Human Cell and Data Repository (U24 - Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
• This funding opportunity was created on 2024-06-24.
• Applicants must submit their applications by 2024-10-17. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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.

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