Opportunity Information: Apply for PA 21 261
The PHS 2021-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer (STTR) Grant Applications (Parent STTR [R41/R42] Clinical Trial Required), funding opportunity number PA-21-261, is a National Institutes of Health (NIH) discretionary grant program designed to support U.S. small businesses that want to develop and translate biomedical and health-related innovations in partnership with a research institution. It uses the STTR mechanism, which is specifically meant to drive technology transfer by requiring a formal collaboration between a small business concern and a U.S. nonprofit research institution (such as a university, medical center, or research institute). The overall purpose is to advance research and development that aligns with the missions of participating NIH Institutes and Centers, and to move promising discoveries toward products and services that can improve health outcomes.
A central requirement of this particular parent announcement is that the application must propose at least one clinical trial, meaning the project is expected to involve prospective research with human participants in which an intervention is evaluated. This makes the opportunity especially relevant for small businesses developing therapeutics, diagnostics, devices, digital health tools, or other interventions that are ready to be tested in people, rather than strictly preclinical concepts. The project topic must fit within the scientific and programmatic interests of one or more participating NIH components, and applicants are directed to use the PHS 2021-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA to identify areas of interest and confirm fit.
The funding instrument is a grant and follows the standard STTR phased structure: Phase I (R41) generally supports early-stage feasibility and proof-of-concept work, while Phase II (R42) supports continued development, refinement, and broader validation, often moving closer to commercialization or broader clinical adoption. While the summary information provided does not list an award ceiling or the expected number of awards, the parent STTR structure typically allows applicants to pursue a staged development pathway, and NIH review and award decisions are generally tied to scientific merit, feasibility, the strength of the commercialization plan, and alignment with institute priorities.
Eligibility is limited to United States small businesses. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, foreign components may be allowed under NIH policy in certain circumstances, as defined in the NIH Grants Policy Statement, which can permit specific, well-justified elements of the project to be performed outside the U.S. when it is scientifically necessary or offers unique resources that cannot be reasonably obtained domestically. Even when foreign components are allowed, the applicant organization itself must still meet the U.S. small business eligibility requirements and remain the primary awardee.
Administrative details from the listing indicate the opportunity was created on July 8, 2021, is administered by the NIH, and had an original closing date of April 5, 2022. The opportunity is associated with multiple CFDA numbers (now commonly referred to under the broader Assistance Listing system), reflecting that multiple NIH awarding components may participate and fund projects under their respective authorities and mission areas across health and related fields. In practical terms, this FOA serves as a broad, omnibus entry point for U.S. small businesses pursuing STTR funding for clinical trial projects, as long as they can clearly match their proposed work to an NIH institute or center mission and to the relevant topic areas described in the PHS 2021-2 research topics document.Apply for PA 21 261
- The National Institutes of Health in the education, environment, health, income security and social services sector is offering a public funding opportunity titled "PHS 2021-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.172, 93.173, 93.213, 93.233, 93.242, 93.273, 93.279, 93.286, 93.307, 93.350, 93.361, 93.393, 93.394, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.840, 93.859, 93.865, 93.866.
- This funding opportunity was created on 2021-07-08.
- Applicants must submit their applications by 2022-04-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
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Frequently Asked Questions (FAQs)
What is this funding opportunity?
This opportunity is the PHS 2021-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer (STTR) Grant Applications (Parent STTR [R41/R42] Clinical Trial Required), funding opportunity number PA-21-261. It is an NIH discretionary grant program intended to support U.S. small businesses developing biomedical and health-related innovations in formal partnership with a U.S. nonprofit research institution.
Which agency runs and administers this program?
The program is administered by the National Institutes of Health (NIH). Multiple NIH Institutes and Centers may participate, depending on whether the proposed project aligns with their missions and priorities.
What is the purpose of the NIH STTR mechanism?
The STTR mechanism is designed to drive technology transfer by requiring a formal collaboration between a U.S. small business and a U.S. nonprofit research institution (for example, a university, medical center, or research institute). The goal is to move promising discoveries and innovations toward products and services that can improve health outcomes.
What does "Parent STTR" mean in this context?
"Parent STTR" refers to a broad, omnibus funding announcement that can support many different project topics, as long as the work fits within the scientific and programmatic interests of one or more participating NIH Institutes or Centers and aligns with the listed research topics for this solicitation cycle.
Is a clinical trial required under this specific announcement?
Yes. A central requirement of PA-21-261 is that the application must propose at least one clinical trial. The project is expected to include prospective research with human participants where an intervention is evaluated.
What kinds of projects are a good fit since a clinical trial is required?
This opportunity is especially relevant for small businesses developing interventions that are ready to be tested in people, such as therapeutics, diagnostics, devices, digital health tools, or other biomedical and health-related interventions. It is not positioned as a strictly preclinical-only pathway because the FOA requires at least one clinical trial.
What types of organizations are eligible to apply?
Eligibility is limited to United States small businesses. The small business must be the applicant organization and primary awardee under NIH STTR requirements.
Are foreign institutions eligible to apply?
No. Foreign institutions are not eligible to apply under this opportunity, and non-U.S. components of U.S. organizations are also not eligible.
Can any part of the project be performed outside the United States?
Potentially. While foreign institutions cannot apply, foreign components may be allowed under NIH policy in certain circumstances when they are well-justified, scientifically necessary, or provide unique resources not reasonably available in the U.S., as described in the NIH Grants Policy Statement. Even if a foreign component is included, the applicant organization must still be a qualifying U.S. small business and remain the primary awardee.
What is the required partnership structure for an STTR award?
The program requires a formal collaboration between a small business concern and a U.S. nonprofit research institution (such as a university, medical center, or research institute). This formal partnership is a defining feature of the STTR mechanism and is specifically meant to promote technology transfer.
What funding instrument is used?
The funding instrument is a grant.
How do the STTR phases work under this opportunity?
The opportunity follows the standard STTR phased structure:
- Phase I (R41) generally supports early-stage feasibility and proof-of-concept work.
- Phase II (R42) supports continued development, refinement, and broader validation, often moving the project closer to commercialization or broader clinical adoption.
Does the listing specify an award ceiling or the expected number of awards?
The summary information provided does not list an award ceiling or the expected number of awards.
What factors are NIH review and award decisions generally tied to for this parent STTR?
Based on the information provided, NIH review and award decisions are generally tied to scientific merit, feasibility, the strength of the commercialization plan, and alignment with the priorities and mission areas of the relevant NIH Institute(s) or Center(s).
How do applicants determine whether their topic fits NIH priorities?
Applicants are directed to use the PHS 2021-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA to identify areas of interest and confirm fit with one or more participating NIH components.
What does it mean that multiple NIH components may participate?
It means that projects across different biomedical and health-related fields may be supported, provided the proposed work clearly aligns with the mission and programmatic interests of at least one participating NIH Institute or Center. Different NIH components may fund projects under their respective authorities and mission areas.
Why are multiple CFDA (Assistance Listing) numbers associated with this opportunity?
Multiple CFDA numbers (now typically referenced under the broader Assistance Listing system) are associated with this opportunity because more than one NIH awarding component may participate and make awards under their distinct program authorities and health-related mission areas.
When was this opportunity created and what was the original closing date?
The listing indicates the opportunity was created on July 8, 2021, and had an original closing date of April 5, 2022.
What is the overall goal of this omnibus STTR clinical trial solicitation?
The overall goal is to advance research and development aligned with the missions of participating NIH Institutes and Centers and to move promising biomedical and health-related innovations toward products and services that can improve health outcomes, specifically through projects that include at least one clinical trial and involve formal small business and research institution collaboration.
Is this opportunity intended as an entry point for many different clinical trial-focused small business projects?
Yes. In practical terms, this FOA serves as a broad, omnibus entry point for U.S. small businesses seeking STTR funding for clinical trial projects, as long as the work matches an NIH mission area and aligns with the PHS 2021-2 research topics guidance.
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