The NIH, through the Office of Research Infrastructure Programs (ORIP) and several NIH institutes, has announced the reissue of funding for the Human Tissue and Organ Research Resource program (U42 Activity Code) under PAR-24-258. This funding opportunity seeks to enhance the availability of diverse human tissue and organ biospecimens for biomedical research, covering both healthy and diseased specimens from multiple bodily systems and tissue types. These resources are essential for advancing studies on a wide array of diseases, including rare and complex conditions. Eligible applicants must demonstrate experience managing human biospecimen resources and provide services to researchers at institutions, research centers, and federal agencies.

Applicants are expected to address the entire life cycle of tissue and organ resources, including procurement, storage, quality control, and distribution, ensuring compliance with HIPAA and other relevant regulations. The program’s requirements also include the establishment of a user-friendly customer service model, disaster recovery plans, and maintaining secure databases that accurately track and safeguard specimen data. The budget for this award is capped at $720,000 in direct costs per year, with a maximum project duration of five years. One award will be granted, contingent on the availability of funds and the quality of applications received.

Only specific institutions and organizations are eligible to apply, including higher education institutions, nonprofits, small businesses, state and local governments, and certain federal and Native American tribal entities. Foreign organizations and non-U.S. entities are ineligible. Institutions are advised to complete necessary registrations, such as SAM, NCAGE, and eRA Commons, before applying. Each application must also meet NIH compliance standards in the Multi-Project (M) instructions and adhere to page limits and specific application components as outlined in the How to Apply - Application Guide.

The application process requires an "Overall" component and specific "Management" and "Resource" components. The Management section must include an administrative plan that details leadership roles, communication strategies with collection and storage sites, and protocols for specimen quality control and ethical compliance. The Resource section should focus on the design and development of the tissue resource, including preservation methods, biohazard safety, data accuracy, and a sustainability plan demonstrating how program income will support ongoing operations.

Evaluation criteria for applications include project significance, innovation, approach, and environment. Specifically, applications will be scored on their ability to facilitate the acquisition, storage, and distribution of human tissues, engage with research communities, and maintain the operational rigor required for high-quality specimen management. Applicants proposing a Pilot Award Program, which would offer limited biospecimens to researchers at no cost to support pilot studies, are encouraged to prioritize applicants from underrepresented groups, early-stage investigators, and those new to translational research.

Applications are due by January 24, 2025, for the first cycle, with an additional submission cycle due on September 26, 2025. The earliest anticipated start dates are December 2025 and July 2026, respectively. Applications will be peer-reviewed for scientific and technical merit, and only the top half will be discussed and scored by review panels. Final funding decisions will take into account scientific merit, program priorities, and budget considerations, with no appeals accepted for initial peer review decisions.