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

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

What is PAR-22-056 trying to fund?

This funding opportunity supports a dependable national research resource for human organs and tissues used in biomedical research. The focus is service-oriented infrastructure: maintaining practical, reliable access to high-quality human specimens for the broader research community.

Is this a traditional research project grant?

No. The described purpose is not to fund a hypothesis-driven research study. It is intended to support an infrastructure-style program that procures, preserves, stores, and distributes human organs and tissues so other scientists can conduct research using standardized, well-documented human materials.

What does "Research Resource for Human Organs and Tissues" mean in practice?

It refers to an organized program that manages the end-to-end pipeline needed to make human specimens available to researchers, including procurement, preservation and storage, and distribution to qualified requesters.

What is the funding mechanism for this opportunity?

The award uses a cooperative agreement mechanism (U42). This typically indicates NIH expects to play an active partnership role in oversight and direction of the resource, with coordinated expectations for operations and performance.

How is a U42 cooperative agreement different from a standard grant?

Based on the description provided, applicants should expect more federal involvement than in a standard research grant. This can include NIH participation in operational oversight, agreed-upon performance metrics, and alignment with community service expectations tied to running the resource.

Are clinical trials allowed under this FOA?

No. The announcement states "Clinical Trial Not Allowed." Activities should be centered on resource development, maintenance, and distribution, not interventional or clinical outcome studies in human participants.

What kinds of activities is the funded resource expected to perform?

The resource is expected to support the full specimen pipeline for the research community. The description explicitly includes facilitating procurement of human organs and tissues, establishing and maintaining preservation and storage capabilities, and operating distribution systems so qualified biomedical researchers can obtain materials efficiently.

What is meant by "continued availability" of specimens?

It means the resource should be stable, dependable, and capable of sustaining access over time. The emphasis is on reliability, timeliness, and maintaining operations so the research community can consistently obtain human specimens when needed.

Does the opportunity specify technical requirements for specimen handling?

The summary provided does not list detailed technical requirements. However, it emphasizes specimen integrity, reliable operations, and trust in provenance, which implies the need for strong preservation, storage, tracking, and documentation practices.

What operational capabilities are implied by the opportunity description?

While not listed as formal requirements in the provided text, the description implies the need for operational capacity to support procurement, preservation/storage to protect specimen integrity, efficient distribution, and systems to track requests and specimen handling so researchers can trust quality and provenance.

Does the opportunity highlight any compliance expectations?

Yes. It emphasizes that access should be ethically compliant and reliable. It also stresses documentation and chain-of-custody style tracking so recipients can trust the provenance and handling conditions of specimens.

Who can apply for this funding opportunity?

Eligibility is described as limited. Non-U.S. (foreign) institutions are not eligible to apply. The source information also indicates small businesses are eligible applicants, suggesting certain non-academic organizations may apply if they can operate a national-scale biomedical resource.

Are foreign institutions eligible to apply?

No. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply.

Can a U.S. organization include a foreign component or foreign site in the project?

No. The information provided states that non-domestic components of U.S. organizations are not eligible, and foreign components (as defined in the NIH Grants Policy Statement) are not allowed.

Does this opportunity allow any foreign involvement at all?

Based on the provided description, 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.

Is the goal to serve a single lab or the wider research community?

The goal is to serve the broader research community by ensuring that qualified biomedical researchers can access high-quality human organs and tissues in a timely and dependable manner.

What types of users are expected to benefit from the resource?

Qualified biomedical researchers who need human organs and tissues for studying human biology and disease are the intended users, especially where human material is difficult to obtain or standardize.

Does the opportunity mention how requests for specimens should be handled?

It does not provide a specific required process in the summary, but it describes the need for procedures to receive requests, verify requester qualifications, track specimens, and document handling conditions and provenance.

What does "limited competition" indicate?

The opportunity title states it is a limited competition. The provided information does not explain the limitation criteria beyond the eligibility restrictions (especially around foreign involvement), so the specific competition limits would need to be confirmed in the full FOA.

What is the main value of this program to NIH and the research ecosystem?

It helps maintain a centralized, dependable supply of human organs and tissues for research, improving continuity and practical access to specimens that enable studies of human biology and disease using real human materials.

Which federal agency administers this opportunity?

This is a National Institutes of Health (NIH) discretionary grant program.

What is the program number or identifier?

The funding opportunity is identified as PAR-22-056.

What are the CFDA numbers associated with this opportunity?

The source lists multiple CFDA numbers: 93.233, 93.351, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.855, and 93.867.

What do the multiple CFDA numbers suggest?

They suggest the program aligns with missions spanning many NIH institutes and centers and supports a resource relevant across multiple biomedical research areas.

When was the record created, and what is the listed closing date?

The record creation date is November 3, 2021, and the original closing date listed is September 25, 2022.

Does the provided information include the award ceiling or number of awards?

No. The provided source fields do not specify an award ceiling or the expected number of awards. Those details would need to be confirmed in the full FOA text.

What is the biggest constraint called out in the eligibility rules?

The most prominent constraint described is the strict prohibition on foreign entities applying and the prohibition on foreign components or non-domestic components of U.S. organizations participating.

If an organization can manage procurement and distribution, is that the kind of capacity NIH is seeking here?

Yes. The opportunity is aimed at supporting a centralized resource that can reliably procure, preserve/store, and distribute human organs and tissues, with credible operational systems for tracking and documentation.