Opportunity Information: Apply for PA 24 246
The PHS 2024-2 Omnibus Solicitation is a parent funding opportunity announcement from the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) that invites U.S. small businesses to apply for Small Business Innovation Research (SBIR) grants under the R43 and R44 mechanisms. The central purpose is to support research and development led by small companies that have the technical capability to create, refine, and test innovative products or approaches that align with NIH and CDC public health and biomedical missions. Because this is an omnibus or "parent" solicitation, it is designed to cover a wide range of scientific and technological areas rather than a single narrow topic, but applicants are expected to target one or more topic areas described in the SBIR/STTR Program Descriptions and Research Topics associated with NIH, CDC, and FDA.
A defining feature of this specific parent solicitation is that it is the "Clinical Trial Required" version. That means the application must propose at least one clinical trial as part of the project. In practical terms, the project is expected to involve prospective research in human participants in which an intervention is assigned and the effects on health-related or behavioral outcomes are evaluated. This requirement shapes the kind of work that is appropriate for the announcement: applicants should be planning clinical evaluation of a drug, biologic, device, diagnostic, digital health tool, preventive intervention, behavioral strategy, or other health-related technology where a clinical trial is necessary to establish feasibility, safety, performance, or efficacy. The clinical trial element is not optional in this NOFO, so projects that are purely preclinical, purely observational, or otherwise not meeting the NIH definition of a clinical trial would not be a fit for this particular announcement.
Eligibility is focused on U.S. small businesses. Foreign organizations are explicitly not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply. However, foreign components, as defined under the NIH Grants Policy Statement, may be allowed in some cases, which typically means certain discrete parts of the work can occur outside the U.S. when there is a strong justification (for example, access to a unique population, resource, or expertise) and the arrangement complies with NIH policy. Even when foreign components are permitted, the applicant organization itself must still be an eligible U.S. small business and must meet SBIR program requirements.
Programmatically, the proposed project must align with the mission interests of at least one participating NIH Institute or Center (IC) or CDC awarding component. Since NIH is made up of many institutes with different scientific priorities, applicants generally need to select the most appropriate IC based on the health condition, technology area, or population focus, and ensure the specific aims clearly map to that ICs mission. The solicitation is broad across health and related domains, reflected in the multiple CFDA numbers listed (including many NIH institutes and program areas). This breadth means projects can span a wide range of biomedical and public health innovations, as long as they are responsive to participating component priorities and include the required clinical trial.
From an administrative standpoint, the opportunity is a discretionary grant funding program with the funding instrument listed as a grant, and the eligible applicant type listed as small businesses. The opportunity number is PA 24 246, and the funding opportunity title is "PHS 2024-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)." The posting indicates an original closing date of 2025-04-05, and a creation date of 2024-07-03. The award ceiling and expected number of awards are not specified in the provided source data, which is common for omnibus solicitations where budgets and award counts can vary widely depending on institute participation, application volume, and appropriations.
In summary, this NOFO is aimed at U.S. small businesses developing health-related innovations that are ready for evaluation in at least one clinical trial, with projects tailored to the mission needs of NIH and CDC components. The best-fit applicants are companies that not only have a strong technical concept, but also have a realistic clinical development plan, an appropriate trial design, and a clear rationale for why their proposed clinical study is necessary to move the product or intervention toward practical use in healthcare or public health settings.Apply for PA 24 246
- 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 2024-2 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): 93.113, 93.142, 93.143, 93.172, 93.173, 93.213, 93.233, 93.242, 93.273, 93.286, 93.307, 93.361, 93.393, 93.394, 93.395, 93.837, 93.838, 93.839, 93.840, 93.847, 93.865, 93.866, 93.867, 93.879.
- This funding opportunity was created on 2024-07-03.
- Applicants must submit their applications by 2025-04-05. (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 the PHS 2024-2 Omnibus Solicitation?
The PHS 2024-2 Omnibus Solicitation is a parent funding opportunity announcement (NOFO) from the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). It invites U.S. small businesses to apply for Small Business Innovation Research (SBIR) grant funding using the R43 and R44 mechanisms.
What is the opportunity number and official title?
The opportunity number is PA 24 246. The title is "PHS 2024-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)."
Who is eligible to apply?
Eligibility is focused on U.S. small businesses that meet SBIR program requirements. The eligible applicant type listed is small businesses.
Are foreign organizations eligible to apply?
No. Foreign organizations are explicitly not eligible to apply under this opportunity.
Can a non-U.S. component of a U.S. organization apply?
No. Non-U.S. components of U.S. organizations are also explicitly not eligible to apply.
Are any foreign activities allowed within an application?
Possibly. The opportunity notes that foreign components (as defined in the NIH Grants Policy Statement) may be allowed in some cases. This generally means certain discrete parts of the work could occur outside the U.S. if there is strong justification (such as access to a unique population, resource, or expertise) and the arrangement complies with NIH policy. The applicant organization must still be an eligible U.S. small business.
Which agencies are involved in this solicitation?
This parent SBIR solicitation is issued by NIH and CDC. It is designed to support projects that align with NIH and CDC public health and biomedical missions. The topic areas referenced also include research topics associated with NIH, CDC, and FDA.
What does it mean that this is an "omnibus" or "parent" solicitation?
It means the announcement is intended to cover a wide range of scientific and technological areas rather than a single narrow topic. Applicants are expected to target one or more topic areas described in the SBIR/STTR Program Descriptions and Research Topics associated with the participating agencies/components.
What is the main purpose of this funding opportunity?
The purpose is to support research and development led by small companies that have the technical capability to create, refine, and test innovative products or approaches aligned with NIH and CDC missions.
Which SBIR mechanisms are included?
The solicitation invites SBIR applications under the R43 and R44 mechanisms.
Is this a grant or a contract?
The funding instrument listed is a grant, and the program is described as a discretionary grant funding program.
Is a clinical trial required under this announcement?
Yes. This is the "Clinical Trial Required" version of the parent SBIR solicitation. The application must propose at least one clinical trial as part of the project.
What kind of clinical trial is expected?
The clinical trial is expected to involve prospective research in human participants where an intervention is assigned and the effects on health-related or behavioral outcomes are evaluated, consistent with the NIH definition of a clinical trial described in the opportunity summary.
Can I apply if my project does not include a clinical trial?
No. The clinical trial element is not optional in this NOFO, so projects that do not propose at least one clinical trial would not be a fit for this particular announcement.
Are purely preclinical projects a fit for this opportunity?
No. The opportunity indicates that projects that are purely preclinical are not a fit for this "Clinical Trial Required" solicitation.
Are purely observational studies a fit for this opportunity?
No. The opportunity indicates that purely observational projects, or projects that otherwise do not meet the NIH definition of a clinical trial, are not a fit for this solicitation.
What types of interventions or technologies could be appropriate for the required clinical trial?
The summary lists examples such as a drug, biologic, device, diagnostic, digital health tool, preventive intervention, behavioral strategy, or other health-related technology where a clinical trial is necessary to establish feasibility, safety, performance, or efficacy.
Do projects need to align to a specific NIH Institute/Center (IC) or CDC component?
Yes. The proposed project must align with the mission interests of at least one participating NIH Institute or Center (IC) or CDC awarding component.
How should an applicant choose the most appropriate NIH Institute or Center?
The summary indicates applicants generally need to select the most appropriate IC based on the health condition, technology area, or population focus, and ensure the specific aims clearly map to that IC's mission.
How broad are the eligible scientific and technical areas?
The solicitation is broad across health and related domains. This breadth is reflected in the multiple CFDA numbers listed (including many NIH institutes and program areas), and it allows a wide range of biomedical and public health innovations as long as they are responsive to participating component priorities and include the required clinical trial.
What is the posted closing date?
The posting indicates an original closing date of 2025-04-05.
What is the creation date shown for this opportunity?
The creation date listed in the provided information is 2024-07-03.
Is the award ceiling listed?
No. The award ceiling is not specified in the provided source data.
Is the expected number of awards listed?
No. The expected number of awards is not specified in the provided source data.
Why might funding amounts and award counts be unspecified for this type of solicitation?
The summary notes this is common for omnibus solicitations where budgets and award counts can vary widely depending on institute participation, application volume, and appropriations.
What kinds of applicants are the best fit for this opportunity?
The best-fit applicants are described as companies with a strong technical concept, a realistic clinical development plan, an appropriate clinical trial design, and a clear rationale for why the proposed clinical study is necessary to move the product or intervention toward practical use in healthcare or public health settings.
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|---|
| Change of Recipient Organization (Type 7 Parent Clinical Trial Optional) Apply for PA 24 254 Funding Number: PA 24 254 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| NIH Research Software Engineer (RSE) Award (R50 Clinical Trials Not Allowed) Apply for RFA OD 24 011 Funding Number: RFA OD 24 011 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Building Sustainable Software Tools for Open Science (R03 Clinical Trial Not Allowed) Apply for RFA OD 24 010 Funding Number: RFA OD 24 010 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, 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 Clinical Trial Required) Apply for PAR 24 226 Funding Number: PAR 24 226 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, 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 Clinical Trial Not Allowed) Apply for PAR 24 225 Funding Number: PAR 24 225 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Limited Competition: Knockout Mouse Phenotyping Project Database (UM1) Apply for RFA RM 15 016 Funding Number: RFA RM 15 016 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Limited Competition: Knockout Mouse Production and Phenotyping Project (UM1) Apply for RFA RM 15 017 Funding Number: RFA RM 15 017 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Administrative Supplements to Promote Diversity in Research and Development Small Businesses SBIR/STTR (Admin Supp Clinical Trial Not Allowed) Apply for PA 24 255 Funding Number: PA 24 255 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Innovation Corps (I-Corps) at NIH Program for NIH and CDC Translational Research (Admin Supp Clinical Trial NOT Allowed) Apply for PA 25 212 Funding Number: PA 25 212 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Dissemination and Implementation Research in Health (R01 Clinical Trial Optional) Apply for PAR 25 144 Funding Number: PAR 25 144 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutions (R15 Clinical Trial Not Allowed) Apply for PAR 25 134 Funding Number: PAR 25 134 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $375,000 |
| NIH Research Project Grant (Parent R01 Clinical Trial Required) Apply for PA 25 305 Funding Number: PA 25 305 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) Apply for PA 25 301 Funding Number: PA 25 301 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required) Apply for PA 25 303 Funding Number: PA 25 303 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Intervention Research to Improve Native American Health (R01 Clinical Trial Optional) Apply for PAR 25 379 Funding Number: PAR 25 379 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Support for Research Excellence (SuRE) Award (R16 Clinical Trial Not Allowed) Apply for PAR 25 414 Funding Number: PAR 25 414 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $100,000 |
| Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship for Students at Institutions Without NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30) Apply for PA 25 425 Funding Number: PA 25 425 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Fellowship (Parent F32) Apply for PA 25 423 Funding Number: PA 25 423 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship for Students at Institutions with NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30) Apply for PA 25 426 Funding Number: PA 25 426 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31) Apply for PA 25 422 Funding Number: PA 25 422 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
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