Limited Competition: Research Resource for Human Organs and Tissues (U42 Clinical Trial Not Allowed) | PAR 22 056

Opportunity Information: Apply for PAR 22 056

The Limited Competition: Research Resource for Human Organs and Tissues (U42 Clinical Trial Not Allowed) funding opportunity (PAR-22-056) is a National Institutes of Health (NIH) discretionary grant program designed to keep a dependable national research resource in place for human organs and tissues used in biomedical research. The core goal is practical and service-oriented: to ensure that scientists who need high-quality human specimens can continue to access them in a timely, reliable, and ethically compliant way. Rather than funding a traditional hypothesis-driven research project, this opportunity supports an infrastructure-style program that makes human tissues and organs available to the broader research community, helping researchers study human biology and disease using real human material that is often difficult to obtain and standardize.

This award uses a cooperative agreement mechanism (U42), which typically means NIH expects to have an active partnership role in the oversight and direction of the resource. In practice, applicants should expect more federal involvement than in a standard research grant, including coordinated expectations around operations, performance metrics, and community service. The announcement also makes clear that clinical trials are not allowed under this FOA, signaling that the work should focus on resource development and distribution activities, not interventional or clinical outcome studies in human participants.

The funded resource is expected to handle the full pipeline needed to support the research community. That includes facilitating procurement of human organs and tissues, establishing and maintaining preservation and storage capabilities that protect specimen integrity, and running distribution systems so qualified biomedical researchers can obtain materials efficiently. The emphasis is on continued availability, meaning the resource should be stable, scalable, and dependable over time. While the announcement summary does not list technical requirements, a resource of this kind generally needs strong operational capacity, quality and consistency controls for specimen handling, and clear procedures for receiving requests, verifying requester qualifications, tracking specimens, and documenting chain-of-custody and handling conditions so researchers can trust the provenance and quality of what they receive.

Eligibility is limited and notably restrictive regarding foreign involvement. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply. Non-domestic components of U.S. organizations are also not eligible, and foreign components (as defined in the NIH Grants Policy Statement) are not allowed. In other words, the program is designed to be run entirely within an allowable U.S.-based organizational structure without foreign components participating as part of the applicant organization or project structure. The source data also lists small businesses as eligible applicants, indicating that the program is open to certain non-academic entities that have the capacity to operate a national-scale biomedical resource, although the full eligibility rules and any limitations beyond that would be contained in the full announcement.

From an administrative standpoint, the opportunity is categorized under health-related funding activity areas, with multiple CFDA numbers associated with NIH institutes and centers (93.233, 93.351, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.855, 93.867), reflecting that the underlying mission spans many areas of biomedical research. The original closing date listed is September 25, 2022, and the record creation date is November 3, 2021. The provided source fields do not specify an award ceiling or the expected number of awards, so those details would need to be confirmed in the full FOA text.

Overall, this funding opportunity is aimed at supporting a centralized, NIH-partnered resource that makes human organs and tissues accessible to qualified researchers, with responsibilities centered on procurement, preservation, and distribution rather than running clinical trials. The program is structured to maintain continuity and reliability of supply, improve the practical availability of human specimens for research, and ensure the resource operates within NIH policy constraints, including strict limitations on foreign organizational participation.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Limited Competition: Research Resource for Human Organs and Tissues (U42 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): 93.233, 93.351, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.855, 93.867.
• This funding opportunity was created on 2021-11-03.
• Applicants must submit their applications by 2022-09-25. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 22 056

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