Opportunity Information: Apply for PA 23 231
PHS 2023-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required) is a federal grant opportunity that supports U.S. small businesses developing health-related innovations that align with the research and development missions of participating National Institutes of Health (NIH) Institutes and Centers and the Centers for Disease Control and Prevention (CDC). It is structured as a parent SBIR solicitation, meaning it functions as a broad, multi-topic gateway for small companies to propose projects across many biomedical, behavioral, clinical, and public health areas, as long as the work fits the stated scientific interests of at least one participating NIH/CDC component. A defining feature of this specific parent announcement is that applicants must propose at least one clinical trial; it is not appropriate for projects that do not involve a clinical trial component.
The award mechanism is SBIR using the R43/R44 grant activity codes, which generally map to the SBIR phased approach: Phase I (R43) supports early-stage proof of concept and feasibility work, while Phase II (R44) supports more advanced research and development activities aimed at moving a technology toward commercialization and broader deployment. In practice, companies use this pathway to de-risk clinical innovations by generating the human-subject evidence needed for regulatory, adoption, reimbursement, or implementation decisions. Because the NOFO is an omnibus solicitation, applicants are expected to anchor their proposed aims in one of the published SBIR/STTR topic areas referenced in the companion program descriptions and research topics document (PHS 2022-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA). That topic alignment is important because it signals which awarding component is likely to consider the project and what kinds of outcomes, populations, and clinical settings are most relevant.
Eligibility is limited to eligible United States small businesses. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply. However, the opportunity notes that foreign components, as defined under the NIH Grants Policy Statement, may be allowed in some circumstances, which typically means discrete parts of the work can be carried out abroad when there is a strong justification (for example, unique patient populations, specialized facilities, or resources not reasonably available in the U.S.), subject to NIH policy and awards management requirements. Even when foreign components are permitted, the applicant organization itself must still be a qualifying U.S. small business, and the overall project must remain consistent with SBIR program rules.
From an applicant standpoint, the core expectation is a well-justified clinical trial embedded in a coherent product-focused development plan. That usually includes a clear statement of the unmet need, the innovation, the target users or patients, and the clinical context; a rigorous trial design that matches the stage of development (such as early feasibility, pilot, pivotal, pragmatic, or implementation-oriented trials, depending on the technology and agency mission); appropriate protections for human subjects; and a credible pathway to commercialization and real-world use. Because NIH and CDC interests vary widely, strong applications typically make the fit to a specific Institute/Center or CDC mission explicit, showing how the clinical trial outcomes will advance both public health impact and product readiness.
Administratively, this is a discretionary grant opportunity issued by NIH (with CDC participation) under a health and education-related activity category, and it is tied to CFDA/assistance listing numbers 93.361, 93.394, 93.395, and 93.867. The opportunity number is PA 23 231, and the original closing date listed is 2024-04-05. The public listing does not specify an award ceiling or expected number of awards in the provided excerpt, which is common for omnibus parent announcements because budgets and award volume often depend on the quality of submissions, available appropriations, and the priorities of participating components.
Overall, this NOFO is best understood as a broad entry point for U.S. small businesses that are ready to test a health-related innovation in humans and can propose at least one clinical trial that is scientifically rigorous, mission-aligned with a participating NIH Institute/Center or CDC program area, and oriented toward eventual commercialization and public health benefit.Apply for PA 23 231
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "PHS 2023-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.361, 93.394, 93.395, 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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FAQs: PHS 2023-2 Omnibus Solicitation (Parent SBIR [R43/R44] Clinical Trial Required) - PA 23 231
What is this grant opportunity?
This is a federal Small Business Innovation Research (SBIR) funding opportunity from the National Institutes of Health (NIH), with participation from the Centers for Disease Control and Prevention (CDC). It supports U.S. small businesses developing health-related innovations that align with the research and development missions of participating NIH Institutes and Centers and CDC program areas.
What does it mean that this is an "omnibus" parent SBIR solicitation?
"Omnibus" and "parent" indicate that the announcement is designed as a broad, multi-topic entry point rather than a narrow, single-topic program. Companies can propose projects across many biomedical, behavioral, clinical, and public health areas, as long as the work fits the scientific interests of at least one participating NIH/CDC component.
Is a clinical trial required under this announcement?
Yes. A defining feature of this specific parent announcement is that applicants must propose at least one clinical trial. Projects that do not include a clinical trial component are not appropriate for this opportunity.
What funding mechanism and grant activity codes are used?
The award mechanism is SBIR using the R43/R44 grant activity codes. These generally correspond to the SBIR phased approach: Phase I (R43) and Phase II (R44).
What is the difference between Phase I (R43) and Phase II (R44) in this SBIR pathway?
Phase I (R43) generally supports early-stage proof of concept and feasibility work. Phase II (R44) generally supports more advanced research and development activities aimed at moving a technology toward commercialization and broader deployment.
What types of innovations are a fit for this program?
The opportunity supports health-related innovations in biomedical, behavioral, clinical, and public health areas, provided the proposed work aligns with the mission and scientific interests of a participating NIH Institute/Center or the CDC and includes at least one clinical trial.
How do applicants show their project fits NIH or CDC priorities?
Applicants are expected to anchor their proposed aims in one of the published SBIR/STTR topic areas referenced in the companion program descriptions and research topics document: "PHS 2022-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA." Topic alignment helps signal which NIH Institute/Center or CDC component is most likely to consider the project and what outcomes, populations, and clinical settings are most relevant.
Who is eligible to apply?
Eligibility is limited to eligible United States small businesses. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply.
Are any foreign activities allowed?
The opportunity notes that foreign components (as defined under the NIH Grants Policy Statement) may be allowed in some circumstances. This typically means discrete parts of the work can be carried out abroad when strongly justified (for example, unique patient populations, specialized facilities, or resources not reasonably available in the U.S.), subject to NIH policy and awards management requirements. Even if a foreign component is permitted, the applicant must still be a qualifying U.S. small business, and the project must remain consistent with SBIR program rules.
What is the core expectation for the application?
The core expectation is a well-justified clinical trial embedded in a coherent, product-focused development plan. The application should connect the clinical trial to moving the innovation forward toward real-world use and commercialization.
What content is typically important in a strong submission (based on the opportunity description)?
Based on the description provided, strong submissions typically include: a clear statement of the unmet need; a clear description of the innovation; identification of target users or patients and the clinical context; a rigorous clinical trial design appropriate to the development stage; appropriate protections for human subjects; and a credible pathway to commercialization and real-world use.
What kinds of clinical trials might be proposed?
The description indicates that trial designs should match the stage of development. Examples mentioned include early feasibility, pilot, pivotal, pragmatic, or implementation-oriented trials, depending on the technology and the NIH/CDC mission fit.
How does commercialization relate to this funding opportunity?
This pathway is commonly used to de-risk clinical innovations by generating human-subject evidence needed for regulatory, adoption, reimbursement, or implementation decisions. Applicants are expected to present a credible pathway to commercialization and broader deployment.
Which agencies and components participate?
NIH is the issuing agency, and CDC participates. The specific scientific fit is expected to be tied to at least one participating NIH Institute/Center or CDC program area as indicated through topic alignment.
What is the opportunity number and identifier?
The opportunity number is PA 23 231, and it is described as the PHS 2023-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required).
When is the closing date?
The original closing date listed in the provided information is 2024-04-05.
Is this a discretionary grant?
Yes. The description characterizes it as a discretionary grant opportunity issued by NIH (with CDC participation).
What is the activity category for this opportunity?
It is described as being under a health and education-related activity category.
What CFDA/Assistance Listing numbers are associated with this opportunity?
The CFDA/Assistance Listing numbers provided are 93.361, 93.394, 93.395, and 93.867.
Is there an award ceiling or a stated expected number of awards?
The provided excerpt does not specify an award ceiling or expected number of awards. The description notes this is common for omnibus parent announcements, where budgets and award volume may depend on submission quality, available appropriations, and participating component priorities.
What is the main reason a project might be considered not appropriate for this NOFO?
A key disqualifier mentioned is the absence of a clinical trial. This announcement is specifically "Clinical Trial Required," and it is not appropriate for projects that do not involve a clinical trial component.
What is the best way to think about this NOFO overall?
It is best understood as a broad entry point for U.S. small businesses that are ready to test a health-related innovation in humans and can propose at least one clinical trial that is rigorous, aligned with a participating NIH Institute/Center or CDC mission, and oriented toward eventual commercialization and public health benefit.
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Applicants also applied for:
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| NIH-DoD-VA Pain Management Collaboratory ? Pragmatic and/or Implementation Science Demonstration Projects ((UG3/UH3) Clinical Trial Required) Apply for RFA AT 24 004 Funding Number: RFA AT 24 004 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| Microglial Pathophysiology in Comorbid Substance Use Disorder (SUD) and HIV (R61/R33 Clinical Trial Not Allowed) Apply for RFA DA 25 014 Funding Number: RFA DA 25 014 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Innovative Research in Cancer Nanotechnology (IRCN; R01 Clinical Trial Not Allowed) Apply for PAR 23 246 Funding Number: PAR 23 246 Agency: National Institutes of Health Category: Education, Health Funding Amount: $475,000 |
| Ending the Epidemic: New Models of Integrated HIV/AIDS, Addiction, and Primary Care Services (R34 Clinical Trial optional) Apply for RFA DA 25 020 Funding Number: RFA DA 25 020 Agency: National Institutes of Health Category: Education, Health Funding Amount: $450,000 |
| Ending the Epidemic: New Models of Integrated HIV/AIDS, Addiction, and Primary Care Services (R01 Clinical Trial required) Apply for RFA DA 25 019 Funding Number: RFA DA 25 019 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Addressing HIV in highest risk sexual and gender minorities (R34 Clinical Trial Required) Apply for RFA DA 25 002 Funding Number: RFA DA 25 002 Agency: National Institutes of Health Category: Education, Health Funding Amount: $225,000 |
| Addressing HIV in Highest Risk Sexual and Gender Minorities (R01 Clinical Trial Optional) Apply for RFA DA 25 001 Funding Number: RFA DA 25 001 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| Secondary Analysis and Integration of Existing Data to Elucidate Cancer Risk and Related Outcomes (R01 Clinical Trial Not Allowed) Apply for PAR 23 254 Funding Number: PAR 23 254 Agency: National Institutes of Health Category: Education, Health Funding Amount: $350,000 |
| Secondary Analysis and Integration of Existing Data to Elucidate Cancer Risk and Related Outcomes (R21 Clinical Trials Not Allowed) Apply for PAR 23 255 Funding Number: PAR 23 255 Agency: National Institutes of Health Category: Education, Health Funding Amount: $275,000 |
| Personal Health Informatics for Delivering Actionable Insights to Individuals (R01 Clinical Trial Optional) Apply for PAR 23 245 Funding Number: PAR 23 245 Agency: National Institutes of Health Category: Education, Health Funding Amount: $250,000 |
| Academic-Industrial Partnerships (AIP) to Translate and Validate In Vivo Imaging Systems (R01 Clinical Trial Optional) Apply for PAR 23 259 Funding Number: PAR 23 259 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| NCI Research Specialist (Core-based Scientist) Award (R50 Clinical Trial Not Allowed) Apply for PAR 23 243 Funding Number: PAR 23 243 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| NCI Research Specialist (Laboratory-based Scientist) Award (R50 Clinical Trial Not Allowed) Apply for PAR 23 242 Funding Number: PAR 23 242 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Assay development and screening for discovery of chemical probes, drugs or immunomodulators (R01 Clinical Trial Not Allowed) Apply for PAR 23 264 Funding Number: PAR 23 264 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Understanding Expectancies in Cancer Symptom Management (R01 Clinical Trial Required) Apply for PAR 23 273 Funding Number: PAR 23 273 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Population Approaches to Reducing Alcohol-related Cancer Risk (R01 Clinical Trial Optional) Apply for PAR 23 244 Funding Number: PAR 23 244 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Screening, Brief Intervention and Referral to Treatment or Prevention (SBIRT/P) for alcohol, tobacco, and other drugs (ATOD) use and misuse in adult populations that experience health disparities (R01, Clinical Trial Required) Apply for PAR 23 270 Funding Number: PAR 23 270 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Device Based Treatments for Substance Use Disorders (UG3/UH3 Clinical Trial Optional) Apply for PAR 23 253 Funding Number: PAR 23 253 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
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