PHS 2021-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed) | PA 21 262

Opportunity Information: Apply for PA 21 262

The PHS 2021-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer (STTR) Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed), Funding Opportunity Number PA-21-262, is a National Institutes of Health (NIH) funding announcement that invites eligible United States small businesses to apply for STTR grant funding to support research and development projects aligned with NIH mission needs. It is structured as a parent omnibus solicitation, meaning it serves as a broad entry point for a wide range of topic areas rather than a single narrowly defined program, and applicants are expected to align their proposal to one of the participating agency component topics listed in the PHS 2021-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA.

The primary purpose of this opportunity is to stimulate technology transfer and commercialization-focused R and D by requiring a formal collaboration between a U.S. small business and a nonprofit research institution (the hallmark of the STTR program). The small business is expected to bring product development and commercialization capability, while the partnering research institution contributes scientific depth and research infrastructure. Projects supported under this announcement are intended to advance innovations that can ultimately address public health needs across NIH-relevant areas, which is reflected in the many CFDA program areas associated with this solicitation (including multiple NIH institute and center portfolios across health-related domains).

Awards under this FOA use the NIH STTR grant mechanisms R41 (Phase I) and R42 (Phase II). In general terms, Phase I is designed to establish feasibility and technical merit, while Phase II supports continued R and D efforts aimed at further development toward commercialization. Because this is a parent solicitation, specific scientific priorities, topic guidance, and any institute- or center-specific expectations are found in the referenced PHS 2021-2 topic document, and applicants typically select the most appropriate awarding component based on fit.

A central restriction in this particular parent FOA is that clinical trials are not allowed. That means applications proposing to conduct a clinical trial as part of the research plan are not responsive to this announcement and would need to be directed to a different NIH funding opportunity that allows clinical trials. The intent here is to support preclinical, technical development, platform development, tool creation, or other non-clinical-trial R and D activities that still contribute to NIH program goals and can position a technology for later-stage testing or adoption through other pathways.

Eligibility is limited to U.S. small businesses. Foreign (non-U.S.) entities are explicitly not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components, as defined under the NIH Grants Policy Statement, may be allowable in some circumstances, which typically means a discrete portion of the project can be performed abroad when it is well justified and consistent with NIH policy. Applicants still need to ensure the applying organization is a qualifying U.S. small business and that the overall project structure remains compliant with STTR requirements.

From an administrative perspective, this is a discretionary grant opportunity offered by the NIH. The listing includes an original closing date of 2022-04-05 and a creation date of 2021-07-08. The public synopsis does not specify an award ceiling or the expected number of awards in the provided fields, which is common for omnibus NIH solicitations where budget caps and award counts can vary by phase, institute, topic area, and year, and where standard NIH and STTR policy limits and guidance often govern budget requests.

In practical terms, the best fit applicants are U.S. small businesses that have a clear innovation with a plausible development path, a strong partner research institution, and a work plan that advances the technology without crossing into conducting a clinical trial. Strong applications typically demonstrate (1) a defined unmet need relevant to an NIH mission area, (2) credible preliminary rationale or feasibility approach appropriate to Phase I or Phase II, (3) a well-structured collaboration and division of work between the company and the research institution, and (4) a commercialization strategy that explains how the work will move beyond the grant period toward real-world impact.

• The National Institutes of Health in the education, environment, food and nutrition, 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 Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.121, 93.172, 93.173, 93.213, 93.233, 93.242, 93.273, 93.279, 93.286, 93.307, 93.350, 93.351, 93.361, 93.393, 93.394, 93.396, 93.399, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.859, 93.865, 93.866, 93.867, 93.879.
• 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.

Apply for PA 21 262

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