Research Resource for Human Organs and Tissues (U42 Clinical Trial Not Allowed)

The National Institutes of Health (NIH), under the Department of Health and Human Services (HHS), has released a reissued Notice of Funding Opportunity (NOFO), PAR-24-258, titled “Research Resource for Human Organs and Tissues (U42 Clinical Trial Not Allowed).” This NOFO is administered by the Office of Research Infrastructure Programs (ORIP), a division within the NIH’s Division of Program Coordination, Planning and Strategic Initiatives. Additional participation has been added from various NIH institutes including the National Eye Institute (NEI), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute on Deafness and Other Communication Disorders (NIDCD), and the National Heart, Lung, and Blood Institute (NHLBI). The purpose of this funding opportunity is to ensure the continued availability of human tissues and organs, both diseased and normal, to qualified biomedical researchers. This initiative supports a Human Tissue and Organ Research Resource program that facilitates the procurement, preservation, and distribution of a wide variety of biospecimens across the biomedical research community. These include samples from multiple body systems such as nervous, cardiovascular, endocrine, renal, pulmonary, and musculoskeletal systems, among others. The biospecimens are intended to support studies on both infectious and non-infectious diseases, and can benefit research on both prevalent public health conditions and rare genetic disorders. Funding will be provided through a U42 cooperative agreement, where significant programmatic involvement from NIH staff is anticipated. The maximum allowable direct costs per application is $720,000, with a project period not to exceed five years. Only new applications are being accepted, and clinical trials are not permitted under this NOFO. Applications must include a multi-component structure with a required Overall Component, Management Component, and Resource Component. The Overall Component should articulate the program’s history, goals, structure, and expected outcomes. The Management Component must detail operational oversight, adherence to quality control and ethical standards, and plans for continuous improvement. The Resource Component is expected to define procurement, preservation, distribution protocols, customer service plans, and sustainability strategies. An optional Pilot Award Program can also be proposed to encourage use of the resource by early-stage investigators. The eligibility for applicants is broad, including higher education institutions (both public and private), nonprofit organizations, for-profit businesses (including small businesses), and various levels of local, state, and tribal governments. However, foreign organizations and foreign components of U.S. organizations are not eligible. Each PD/PI must have a valid eRA Commons ID, and the institution must be registered in multiple federal systems such as SAM.gov, eRA Commons, and Grants.gov. Applications can be submitted starting December 24, 2024, with two major deadlines on January 24, 2025, and September 26, 2025. All applications must be submitted electronically through ASSIST or institutional system-to-system (S2S) solutions and must comply strictly with NIH’s How to Apply Application Guide. Applicants are encouraged to apply early to allow time to correct errors. The earliest project start dates are December 2025 and July 2026, depending on the application cycle. Recipients are expected to participate in collaborative activities with NIH and will be subject to programmatic evaluations and progress reporting. For scientific inquiries, the primary contact at ORIP is Dr. Stephanie Murphy (stephanie.murphy@nih.gov, 301-451-7818). Additional contacts are listed for each participating institute. For submission questions, the eRA Service Desk and Grants.gov support lines are available. The application must address NIH policies including data management and sharing plans, human subjects protections, and resource sharing requirements. The funding announcement remains open through September 26, 2025.

Applicants should use the NIH ASSIST system or institutional S2S tools, follow the multi-component (M) application guide closely, and submit early to allow correction of submission errors.