Opportunity Information: Apply for PA 23 233
The PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer (STTR) Grant Applications (Parent STTR [R41/R42] Clinical Trial Required), funding opportunity number PA 23-233, is a discretionary NIH grant program designed specifically for eligible U.S. small businesses that want to move biomedical or health-related technologies forward through a formal collaboration with a research institution. It uses the STTR mechanism (R41/R42), which is NIH's main pathway for supporting early-stage innovation where a small business partners with a nonprofit research organization, such as a university or research hospital, to conduct research and development that aligns with NIH public health priorities.
A defining feature of this particular parent announcement is that it is "Clinical Trial Required." In practical terms, that means applications submitted under this NOFO must propose at least one clinical trial as part of the project. The clinical trial requirement signals that NIH is looking for small business-led projects that are ready to be tested in humans, not just proven in a lab or in animal studies. Applicants are expected to plan and carry out a clinical study that fits NIH's definition of a clinical trial and is appropriate for the technology or intervention being developed, whether that is a therapeutic, medical device, diagnostic, digital health tool, or another clinical innovation.
The opportunity is "omnibus" in the sense that it serves as a broad parent solicitation across many NIH Institutes and Centers (ICs), with topic areas described in the companion resource referenced in the notice: the PHS 2023-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA. Applicants are expected to pick a topic that matches their project and to ensure the proposed work aligns with the programmatic interests and scientific mission of at least one participating NIH Institute or Center. Fit matters here: even if a project is scientifically strong, it still needs to connect clearly to the priorities of the NIH component that would potentially fund it.
Eligibility is limited to U.S. small businesses. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. That said, the notice indicates that "foreign components" may be allowed as defined by the NIH Grants Policy Statement, which typically means that specific elements of the work may be performed outside the U.S. if they are well-justified, clearly necessary, and compliant with NIH policy, but the applicant organization itself must remain an eligible U.S. small business concern.
From an administrative standpoint, the sponsoring agency is the National Institutes of Health, and the funding instrument type is a grant under the STTR R41/R42 structure. The activity spans health-related areas captured under multiple CFDA numbers (including, among others, 93.113, 93.173, 93.213, 93.233, 93.242, 93.273, 93.279, 93.286, 93.307, 93.361, 93.394, 93.395, 93.837, 93.838, 93.839, 93.840, 93.865, 93.866, and 93.867), reflecting the wide range of NIH programs that can support STTR projects. The posting lists an original closing date of 2024-04-05. The public listing does not specify an award ceiling or the expected number of awards, which often means those details can vary by institute, topic area, and available appropriations, and applicants typically need to consult NIH and institute guidance for budget expectations under the STTR mechanism.
Overall, this NOFO is aimed at small businesses that are beyond purely exploratory research and are prepared to propose a structured, compliant clinical trial as part of a commercialization-oriented development plan. Successful applications generally need to show a strong scientific rationale, a credible and well-managed small business/research institution partnership, a clear clinical trial design and operational plan, and a compelling case that the work advances an NIH-relevant healthcare need and can realistically move toward practical use in the real world.Apply for PA 23 233
- The National Institutes of Health in the education, environment, health, income security and social services sector is offering a public funding opportunity titled "PHS 2023-2 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, 93.173, 93.213, 93.233, 93.242, 93.273, 93.279, 93.286, 93.307, 93.361, 93.394, 93.395, 93.837, 93.838, 93.839, 93.840, 93.865, 93.866, 93.867.
- This funding opportunity was created on 2023-07-12.
- Applicants must submit their applications by 2024-04-05. (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)
1) What is the PA 23-233 funding opportunity?
PA 23-233 is the PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer (STTR) Grant Applications (Parent STTR [R41/R42] Clinical Trial Required). It is a discretionary NIH grant program that supports eligible U.S. small businesses developing biomedical or health-related technologies through a formal collaboration with a nonprofit research organization.
2) Which agency sponsors this opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
3) What funding mechanism does this program use?
This opportunity uses the NIH STTR mechanism under the R41/R42 structure (a grant funding instrument type).
4) Who is this program designed for?
It is designed specifically for eligible U.S. small businesses that want to move biomedical or health-related technologies forward in collaboration with a research institution.
5) What makes this parent STTR announcement different from others?
A defining feature is that it is "Clinical Trial Required." Applications submitted under this NOFO must propose at least one clinical trial as part of the project.
6) Does my application have to include a clinical trial?
Yes. Under this specific NOFO, applicants must propose at least one clinical trial that fits NIH's definition of a clinical trial and is appropriate for the technology or intervention being developed.
7) What does "Clinical Trial Required" mean in practical terms?
It means NIH is looking for projects that are ready to be tested in humans as part of the proposed work, rather than projects limited to laboratory studies or animal studies. The application is expected to include planning and execution of a clinical study that meets NIH requirements.
8) What kinds of technologies or interventions are relevant for this opportunity?
The opportunity is aimed at biomedical or health-related technologies that can be evaluated in a clinical trial, including examples like therapeutics, medical devices, diagnostics, and digital health tools, as well as other clinical innovations.
9) What is the STTR collaboration requirement?
STTR is NIH's pathway for supporting early-stage innovation where a small business partners with a nonprofit research organization (such as a university or research hospital) to conduct research and development aligned with NIH public health priorities.
10) What does it mean that this is an "omnibus" solicitation?
"Omnibus" means this is a broad parent solicitation that can apply across many NIH Institutes and Centers (ICs), rather than being limited to a single, narrow topic area.
11) How do applicants choose the right topic area?
Applicants are expected to pick a topic that matches their project and aligns with the programmatic interests and scientific mission of at least one participating NIH Institute or Center. Topic areas are described in the companion resource referenced in the notice: the PHS 2023-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA.
12) How important is institute or center "fit" for this NOFO?
Fit is critical. Even if a project is scientifically strong, it still needs to connect clearly to the priorities of the NIH Institute or Center that would potentially fund it.
13) Are foreign organizations eligible to apply?
No. Eligibility is limited to U.S. small businesses. Foreign institutions are not eligible to apply.
14) Are non-U.S. components of U.S. organizations eligible to apply?
No. Non-U.S. components of U.S. organizations are also not eligible to apply under this opportunity.
15) Are any foreign activities allowed as part of the project?
The notice indicates that "foreign components" may be allowed as defined by the NIH Grants Policy Statement. In general terms, this means specific elements of the work may be performed outside the U.S. if they are well-justified, clearly necessary, and compliant with NIH policy, while the applicant organization must remain an eligible U.S. small business concern.
16) What is the main goal of NIH in offering this program?
The program aims to support small business-led projects that can advance NIH-relevant public health priorities by developing clinically oriented innovations through a small business and research institution partnership, including a structured clinical trial.
17) What kinds of project readiness does NIH appear to be looking for here?
Based on the "Clinical Trial Required" feature and the description provided, this NOFO targets small businesses that are beyond purely exploratory research and are prepared to propose a structured, compliant clinical trial as part of a commercialization-oriented development plan.
18) What elements are typically important for a competitive application under this opportunity?
The description emphasizes several factors: a strong scientific rationale, a credible and well-managed small business/research institution partnership, a clear clinical trial design and operational plan, and a compelling case that the work advances an NIH-relevant healthcare need and can realistically move toward practical use in the real world.
19) What is the funding opportunity number for this program?
The funding opportunity number is PA 23-233.
20) What is the application closing date listed in the public posting?
The posting lists an original closing date of 2024-04-05.
21) Is an award ceiling stated in the public listing?
No. The public listing does not specify an award ceiling.
22) Does the public listing state the expected number of awards?
No. The public listing does not specify the expected number of awards.
23) Why might award size and award count not be specified?
The information provided suggests these details can vary by institute, topic area, and available appropriations. Applicants may need to consult NIH and institute guidance for budget expectations under the STTR mechanism.
24) Which program areas or CFDA numbers are associated with this opportunity?
The activity spans multiple health-related areas captured under multiple CFDA numbers. Examples listed include 93.113, 93.173, 93.213, 93.233, 93.242, 93.273, 93.279, 93.286, 93.307, 93.361, 93.394, 93.395, 93.837, 93.838, 93.839, 93.840, 93.865, 93.866, and 93.867, reflecting the wide range of NIH programs that can support STTR projects.
25) What type of research organization partner is contemplated in the description?
The description references nonprofit research organizations such as universities or research hospitals as examples of eligible research institution partners in an STTR collaboration.
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| Single Source: NIH Blueprint for Neuroscience Research: NeuroImaging Tools and Resources Collaboratory (R24 Clinical Trial Not Allowed) Apply for RFA EB 23 007 Funding Number: RFA EB 23 007 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: $700,000 |
| NIH Blueprint and BRAIN Initiative Program for Enhancing Neuroscience Diversity through Undergraduate Research Education Experiences (BP BRAIN-ENDURE) (R25 Clinical Trial Not Allowed) Apply for RFA NS 24 014 Funding Number: RFA NS 24 014 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Ethical, Legal and Social Implications (ELSI) Research (R01 Clinical Trial Optional) Apply for PAR 23 293 Funding Number: PAR 23 293 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Ethical, Legal and Social Implications (ELSI) Exploratory/Developmental Research Grant (R21 Clinical Trial Optional) Apply for PAR 23 294 Funding Number: PAR 23 294 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: $275,000 |
| Ethical, Legal and Social Implications (ELSI) Small Research Grant (R03 Clinical Trial Optional) Apply for PAR 23 295 Funding Number: PAR 23 295 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: $50,000 |
| BRAIN Initiative: Marmoset Colonies for Neuroscience Research (U24 Clinical Trials Not Allowed) Apply for RFA MH 25 115 Funding Number: RFA MH 25 115 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Marmoset Coordination Center (U24 Clinical Trials Not Allowed) Apply for RFA MH 25 116 Funding Number: RFA MH 25 116 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| NIH Blueprint and BRAIN Initiative Diversity Specialized Predoctoral to Postdoctoral Advancement in Neuroscience (D-SPAN) Award (F99/K00 Clinical Trial Not Allowed) Apply for RFA NS 24 030 Funding Number: RFA NS 24 030 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Basic Experimental Studies with Humans Required) Apply for PA 24 186 Funding Number: PA 24 186 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Mentored Quantitative Research Development Award (Parent K25 Independent Basic Experimental Studies with Humans Required) Apply for PA 24 192 Funding Number: PA 24 192 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Required) Apply for PA 24 181 Funding Number: PA 24 181 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Basic Experimental Studies with Humans Required) Apply for PA 24 183 Funding Number: PA 24 183 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Mentored Research Scientist Development Award (Parent K01 Independent Basic Experimental Studies with Humans Required) Apply for PA 24 177 Funding Number: PA 24 177 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| NIH Pathway to Independence Award (Parent K99/R00 Independent Basic Experimental Studies with Humans Required) Apply for PA 24 195 Funding Number: PA 24 195 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Small Business Transition Grant for New Entrepreneurs (R41/R42 Clinical Trial Not Allowed) Apply for PAR 24 133 Funding Number: PAR 24 133 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| PHS 2024-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required) Apply for PA 24 248 Funding Number: PA 24 248 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) Postdoctoral Career Transition Award to Promote Diversity (K99/R00 - Independent Basic Experimental Studies with Humans Required (BESH)) Apply for PAR 24 227 Funding Number: PAR 24 227 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Human Brain Single-cell Genomics Explorer (U24 - Clinical Trial Not Allowed) Apply for RFA NS 24 038 Funding Number: RFA NS 24 038 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: $1,000,000 |
| Environmental Health Disparities Centers (P50) Clinical Trial Optional Apply for RFA MD 24 010 Funding Number: RFA MD 24 010 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Dissemination and Implementation Research in Health (R03 Clinical Trial Not Allowed) Apply for PAR 25 233 Funding Number: PAR 25 233 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
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