Opportunity Information: Apply for PA 19 271
The PHS 2019-02 Omnibus Solicitation (Parent STTR R41/R42) Clinical Trial Required funding opportunity, listed as PA 19-271, is a National Institutes of Health (NIH) grant program designed to support U.S. small business concerns that want to move biomedical and behavioral health innovations toward real-world use through research and development that includes human clinical testing. It sits under the Small Business Technology Transfer (STTR) program, which is specifically built around a formal partnership between a small business and a nonprofit research institution (such as a university, hospital, or research institute). The central goal is to help small businesses translate promising science into products, services, or technologies that align with NIH public health missions, while leveraging academic or nonprofit research strengths to strengthen the project and speed development.
A defining feature of this particular Parent announcement is that it is “Clinical Trial Required,” meaning applicants must propose at least one clinical trial as part of the project. In practical terms, this points to projects that have progressed beyond early concept work and are ready to be evaluated in humans, whether to test safety, feasibility, early efficacy, clinical performance, or other predefined outcomes depending on the trial design and stage of development. The trial requirement also means the application needs to be structured to meet NIH expectations for clinical research oversight and planning, such as having clear endpoints, appropriate study design, recruitment plans, data and safety monitoring where applicable, and the ability to meet regulatory and ethical requirements. The clinical trial component is not optional under this FOA, so proposals that do not include a qualifying clinical trial would not be responsive.
The opportunity is described as an omnibus solicitation, which means it is a broad, multi-institute “parent” mechanism rather than a narrow, single-topic call. Applicants are expected to align their proposal with the programmatic interests of one or more participating NIH Institutes and Centers (ICs). NIH publishes topic and mission guidance for this omnibus solicitation through the associated PHS 2019-2 SBIR/STTR Program Descriptions and Research Topics document, and applicants typically use that to identify which IC is the best fit for the science area, disease or condition focus, population, or technology type. Because NIH has many different components with different scientific missions, this parent structure provides a common application pathway while still requiring that each project clearly match an IC’s priorities.
Eligibility is focused on U.S. small businesses. The FOA makes it clear that non-domestic (non-U.S.) entities, including foreign institutions, are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. At the same time, it notes that “foreign components,” as defined in the NIH Grants Policy Statement, may be allowed in some cases. That distinction matters: it generally means the applicant organization must be a U.S.-based small business meeting SBA and NIH requirements, but certain limited portions of the work might be carried out abroad if they meet NIH rules, are well-justified, and are allowable under policy. Applicants considering any foreign component typically need to address why the foreign element is necessary and how oversight and compliance will be handled.
The funding instrument is a grant under the STTR phased structure, using R41 (Phase I) and R42 (Phase II). Phase I is usually used to establish feasibility and the scientific and technical merit of the approach, while Phase II generally supports more advanced development, validation, and steps toward commercialization. Because this specific parent announcement requires a clinical trial, the work proposed in one or both phases must include at least one clinical trial, which often implies a relatively advanced development plan and readiness for human testing. Applicants are expected to present a coherent, milestone-driven R and D plan and to frame the work in a way that shows a path toward product development and eventual impact in healthcare.
The NIH is the issuing agency, and the opportunity appears in a broad set of program areas reflected by the listed funding activity categories (including health, environment, food and nutrition, education, and social services) and the multiple CFDA numbers provided, which correspond to NIH institutes and programs that may participate. The posting indicates an original closing date of 2020-07-06 for that cycle. The award ceiling and expected number of awards are not specified in the provided source data, which typically means applicants would need to consult the FOA text and NIH budget guidelines for STTR to understand standard budget limits, caps, and any IC-specific variations.
Overall, this FOA is meant for U.S. small businesses that are ready to collaborate with a research institution to run at least one clinical trial tied to a technology or intervention with commercial potential and strong alignment to NIH institute missions. It is especially relevant for companies developing therapeutics, diagnostics, devices, digital health tools, or other clinical innovations that have reached a point where human testing is appropriate and necessary to advance the product toward regulatory acceptance, adoption, and real patient or public health benefit.Apply for PA 19 271
- 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 2019-02 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, 93.121, 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, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.856, 93.859, 93.865, 93.866, 93.867, 93.879.
- This funding opportunity was created on 2019-05-07.
- Applicants must submit their applications by 2020-07-06. (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): NIH Parent STTR (R41/R42) Clinical Trial Required (PA-19-271)
1. What is this funding opportunity?
This is the PHS 2019-02 Omnibus Solicitation (Parent STTR R41/R42) "Clinical Trial Required" funding opportunity from the National Institutes of Health (NIH). It is listed as PA-19-271 and supports U.S. small businesses conducting research and development (R&D) to move biomedical and behavioral health innovations toward real-world use, specifically including human clinical testing.
2. Which agency runs this program?
The issuing agency is the National Institutes of Health (NIH).
3. What program is this under: SBIR or STTR?
This opportunity is under the Small Business Technology Transfer (STTR) program.
4. What is the main purpose of the STTR program in this announcement?
The central purpose is to help U.S. small businesses translate promising science into products, services, or technologies that align with NIH public health missions, while leveraging the strengths of a nonprofit research institution partner (such as a university, hospital, or research institute) to strengthen the project and speed development.
5. Is a partnership required?
Yes. STTR is built around a formal partnership between a small business and a nonprofit research institution.
6. What does "Parent" or "omnibus solicitation" mean here?
This is a broad, multi-institute parent mechanism rather than a narrow, single-topic call. Applicants still need to align their proposed project with the programmatic interests of one or more participating NIH Institutes and Centers (ICs).
7. What does "Clinical Trial Required" mean?
It means applicants must propose at least one clinical trial as part of the project. The clinical trial component is not optional under this funding opportunity.
8. What happens if an application does not include a clinical trial?
Based on the requirement stated for this FOA, a proposal that does not include a qualifying clinical trial would not be responsive.
9. What kinds of outcomes can the clinical trial evaluate?
The clinical trial may be designed to test safety, feasibility, early efficacy, clinical performance, or other predefined outcomes, depending on the trial design and stage of development described in the application.
10. What does the clinical trial requirement imply about project maturity?
In practical terms, it points to projects that have progressed beyond early concept work and are ready to be evaluated in humans.
11. Are there special expectations for planning and oversight because this involves a clinical trial?
Yes. The application needs to be structured to meet NIH expectations for clinical research oversight and planning. The provided information highlights elements such as clear endpoints, appropriate study design, recruitment plans, data and safety monitoring (where applicable), and the ability to meet regulatory and ethical requirements.
12. Who is eligible to apply?
Eligibility is focused on U.S. small business concerns that meet SBA and NIH requirements.
13. Are non-U.S. (foreign) entities eligible to apply?
No. Non-domestic (non-U.S.) entities, including foreign institutions, are not eligible to apply under this FOA.
14. Can a non-domestic component of a U.S. organization apply?
No. The FOA indicates that non-domestic components of U.S. organizations are not eligible to apply.
15. Are "foreign components" allowed at all?
The information provided notes that "foreign components," as defined in the NIH Grants Policy Statement, may be allowed in some cases. This typically means the applicant must be a U.S.-based small business, but certain limited portions of the work might be carried out abroad if allowable, well-justified, and compliant with NIH policy.
16. If a foreign component is included, what should applicants be prepared to explain?
Applicants considering any foreign component typically need to address why the foreign element is necessary and how oversight and compliance will be handled.
17. What are the funding instruments and phases?
The funding instrument is an NIH grant under the STTR phased structure, using R41 (Phase I) and R42 (Phase II).
18. What is the difference between Phase I (R41) and Phase II (R42) in this context?
Phase I is usually used to establish feasibility and the scientific and technical merit of the approach. Phase II generally supports more advanced development, validation, and steps toward commercialization.
19. In which phase must the clinical trial occur?
The information provided indicates that the work proposed in one or both phases must include at least one clinical trial. The key point is that at least one clinical trial is required as part of the overall project proposed under this FOA.
20. How should applicants choose the right NIH Institute or Center (IC) for their application?
Applicants are expected to align the proposal with the programmatic interests of one or more participating NIH Institutes and Centers. NIH publishes topic and mission guidance for this omnibus solicitation through the associated PHS 2019-2 SBIR/STTR Program Descriptions and Research Topics document, which applicants typically use to identify the best IC fit.
21. What areas or fields does this opportunity cover?
The opportunity is described as spanning a broad set of program areas, reflected by the listed funding activity categories (including health, environment, food and nutrition, education, and social services) and multiple CFDA numbers corresponding to NIH institutes and programs that may participate.
22. What types of projects are a good fit?
This FOA is especially relevant for companies developing therapeutics, diagnostics, devices, digital health tools, or other clinical innovations that have reached a point where human testing is appropriate and necessary to advance the product toward real-world use and public health impact.
23. What is NIH looking for beyond the science?
Applicants are expected to present a coherent, milestone-driven R&D plan and frame the work in a way that shows a path toward product development and eventual impact in healthcare, consistent with STTR goals of translation and commercialization.
24. Are award amounts (ceiling) and number of awards provided?
No. The provided source data does not specify an award ceiling or an expected number of awards. Applicants would typically need to consult the full FOA text and NIH budget guidelines for STTR to understand standard budget limits, caps, and any Institute- or Center-specific variations.
25. What is the closing date mentioned for this cycle?
The posting indicates an original closing date of 2020-07-06 for that cycle.
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Applicants who have applied for this opportunity (PA 19 271) also looked into and applied for these:
| Funding Opportunity |
|---|
| PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed Apply for PA 19 270 Funding Number: PA 19 270 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional) Apply for PA 20 135 Funding Number: PA 20 135 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed) Apply for PA 20 166 Funding Number: PA 20 166 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| NIH Pathway to Independence Award (Parent K99/R00 Independent Clinical Trial Required) Apply for PA 20 187 Funding Number: PA 20 187 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 20 185 Funding Number: PA 20 185 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| NIH Pathway to Independence Award (Parent K99/R00 Independent Clinical Trial Not Allowed) Apply for PA 20 188 Funding Number: PA 20 188 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Mentored Quantitative Research Development Award (Parent K25 Independent Clinical Trial Required) Apply for PA 20 197 Funding Number: PA 20 197 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| NIH Support for Conferences and Scientific Meetings (Parent R13 Clinical Trial Not Allowed) Apply for PA 20 207 Funding Number: PA 20 207 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Clinical Trial Required) Apply for PA 20 206 Funding Number: PA 20 206 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Clinical Trial Not Allowed) Apply for PA 20 205 Funding Number: PA 20 205 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Not Allowed) Apply for PA 20 203 Funding Number: PA 20 203 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed) Apply for PA 20 222 Funding Number: PA 20 222 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Administrative Supplement for Research on Dietary Supplements (Admin Supp-Clinical Trial Not Allowed) Apply for PA 20 227 Funding Number: PA 20 227 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $1,000,000 |
| Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Fellowship (Parent F32) Apply for PA 20 242 Funding Number: PA 20 242 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 20 246 Funding Number: PA 20 246 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 Without NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30) Apply for PA 20 245 Funding Number: PA 20 245 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 20 248 Funding Number: PA 20 248 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 to Promote Diversity in Health-Related Research (Parent F31-Diversity) Apply for PA 20 251 Funding Number: PA 20 251 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required) Apply for PA 20 261 Funding Number: PA 20 261 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required) Apply for PA 20 262 Funding Number: PA 20 262 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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