Technology Development Research for Establishing Feasibility and Proof of Concept (R21 - Clinical Trial Not Allowed) | PAR 22 126

Frequently Asked Questions (FAQs)

What is this NIH funding opportunity?

This opportunity is the National Institutes of Health (NIH) Technology Development Research for Establishing Feasibility and Proof of Concept program using the R21 mechanism (Clinical Trial Not Allowed), FOA PAR-22-126. It supports early, exploratory technology development intended to establish feasibility and proof of concept for genuinely new biomedical research technologies.

What is the main goal of PAR-22-126?

The goal is to fund high-risk, high-reward projects that invent, build, or demonstrate new technologies (methods, platforms, tools, or approaches) and perform proof-of-concept experiments showing the core idea could work. The emphasis is on creating and validating an enabling technology, not on using it to answer a specific biomedical or clinical research question.

What kinds of projects are a good fit for this FOA?

Projects that are still unproven and need carefully designed feasibility testing are the best fit. Strong candidates are bold, unconventional technology concepts where key technical components must be demonstrated, key performance characteristics must be established, and the central concept must be de-risked enough to justify later-stage development or future application-focused studies under other mechanisms.

What does "technology development" mean in this announcement?

In this FOA, technology development refers to work focused on inventing, building, improving, or demonstrating a new technical capability (for example, a novel method, platform, tool, or approach) and running proof-of-concept studies to verify that the enabling capability is feasible.

Is this program meant to fund studies that use the technology to answer a biomedical question?

No. Proposals should not include aims that apply the technology to specific biomedical questions as part of the funded work. Application-driven aims are described as outside the scope of this FOA and are not fundable under this announcement.

What should the proposed aims focus on instead of downstream applications?

The aims should focus on establishing feasibility of the technology itself. That includes demonstrating essential technical components, verifying key performance characteristics, and showing proof-of-concept results that indicate the core technological idea is viable.

Are clinical trials allowed under this R21?

No. This is an R21 opportunity labeled "Clinical Trial Not Allowed," so proposed work should not be structured as a clinical trial under this announcement.

How does NIH define "feasibility" expectations for this opportunity?

A defining feature is that NIH is looking for projects where feasibility has not already been shown, either in the published literature or through preliminary results generated by the applicants. The intent is to support truly exploratory concepts rather than projects that already look likely to succeed.

Can applicants include unpublished preliminary data in the application?

No. The FOA prohibits including unpublished preliminary data. The rationale is that such data can be interpreted as forecasting the likelihood of success, which conflicts with the program's intent to support exploratory, unproven concepts.

Can published literature be cited in the proposal?

Yes. Applicants may cite published studies to describe the current state of the art and to clarify why the proposed technology is new or potentially transformative. However, publications cannot be used to claim that the proposed approach is already likely to succeed.

Are preprints allowed as references?

Yes, with an important condition. Widely available preprints are acceptable if they have a Digital Object Identifier (DOI), meaning they can be referenced similarly to other public sources.

Are privately held or otherwise non-public results allowed?

No. Privately held or otherwise unpublished data should not be included, consistent with the FOA's prohibition on unpublished preliminary results.

What makes this a "high-risk, high-reward" program?

The program is intentionally designed to support concepts that are bold and unconventional, where success is uncertain but the payoff could be substantial. The eventual impact may be far in the future, but the funded work should establish feasibility and proof of concept for the core technology.

What is the funding mechanism used for this opportunity?

The FOA uses the NIH R21 mechanism, which is commonly associated with exploratory and developmental research projects.

What is the assistance listing / CFDA information for this program?

The opportunity lists CFDA (assistance listing) numbers 93.394, 93.859, and 93.866, and it is categorized under Education and Health.

When is the closing date listed in the provided information?

The listed original closing date is 2025-05-07.

When was this opportunity created?

The opportunity was created on 2022-03-21.

Does the provided information specify an award ceiling or the expected number of awards?

No. The provided source does not specify an award ceiling or the expected number of awards. Applicants would need to consult the full NIH funding announcement and related NIH policy guidance for details such as budget structure, project period expectations, and institute-specific participation.

Who is eligible to apply (in general terms)?

Eligibility is broad across U.S.-based organizational types, including many government, academic, nonprofit, and private-sector entities, as described in the provided information.

What U.S. government entities are eligible?

Eligible applicants include state governments; county governments; city or township governments; special district governments; and eligible federal agencies.

Are educational institutions eligible to apply?

Yes. Eligible applicants include independent school districts, public and state-controlled institutions of higher education, and private institutions of higher education. The announcement also highlights several institution types such as HBCUs, TCCUs, Hispanic-serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISI organizations.

Are nonprofit organizations eligible?

Yes. Nonprofits are eligible whether or not they have 501(c)(3) status, based on the eligibility list provided.

Are for-profit organizations eligible?

Yes. For-profit organizations (other than small businesses) are eligible, and small businesses are also listed as eligible.

Are tribal entities eligible to apply?

Yes. Eligible applicants include federally recognized Native American tribal governments and Native American tribal organizations other than federally recognized governments. The announcement also mentions Indian/Native American tribal governments other than federally recognized.

Are public housing authorities eligible?

Yes. Public housing authorities and Indian housing authorities are included as eligible applicants.

Are faith-based or community-based organizations eligible?

Yes. The announcement highlights faith-based or community-based organizations as eligible applicant types.

Are regional organizations eligible?

Yes. Regional organizations are listed among additional eligible applicants.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are included among the additional eligible applicants listed.

Can a non-U.S. (foreign) organization apply as the applicant?

No. Non-domestic (non-U.S.) entities and non-domestic institutions are not eligible to apply as the applicant organization under this announcement.

Can a non-domestic component of a U.S. organization apply?

No. Non-domestic (non-U.S.) components of U.S. organizations are also not eligible to apply under this announcement.

Are foreign components allowed at all?

Yes. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. This generally means a U.S. applicant may include certain foreign collaborations or performance sites when well-justified and consistent with NIH policy, even though the primary applicant organization must be domestic.

What should a competitive application look like based on the description provided?

A competitive submission should read like a focused technology development plan. It should clearly explain what is new, why current approaches fall short, what technical barriers remain, and what feasibility milestones and proof-of-concept experiments will demonstrate that the core technological idea is viable, without relying on unpublished preliminary results and without shifting into application-driven biomedical studies.

Can applicants use published studies to argue their project is low-risk?

No. While published studies can be cited for state-of-the-art context, the FOA emphasizes that applicants cannot use publications to claim the proposed approach is already likely to succeed. The program is intended for concepts where feasibility has not already been established.

If the project becomes successful, is it expected to immediately produce near-term biomedical impact?

Not necessarily. The program supports enabling technologies where the payoff could be substantial even if the eventual impact is still far in the future, as long as the proposed work establishes feasibility and proof of concept for the technology itself.