Opportunity Information: Apply for PA 19 273
The PHS 2019-02 Omnibus Solicitation (PA 19-273) is a federal SBIR grant opportunity run jointly by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA). It is designed to fund U.S. small business concerns that can develop innovative products, processes, or technologies that support the research and development missions of these agencies. In practical terms, the solicitation acts as a broad "parent" umbrella: instead of being limited to one narrow disease area or technology, applicants propose projects that align with the scientific priorities of one or more participating NIH Institutes and Centers (and relevant CDC or FDA components) and respond to the topic areas laid out in the companion PHS 2019-2 SBIR/STTR Program Descriptions and Research Topics document.
This specific parent announcement is the SBIR R43/R44 pathway and is labeled "Clinical Trial Required," which is a major defining feature. That means the application must include at least one clinical trial as part of the proposed work. The expectation is not just preclinical development or bench research, but a plan that advances into human subjects research where an intervention is prospectively assigned and outcomes are evaluated. The clinical trial requirement signals that the agencies want to support small businesses that are ready to test safety, feasibility, performance, or early efficacy in people, typically as part of moving a product toward commercialization and eventual public health impact.
Eligibility is restricted to U.S. small business concerns. Foreign institutions cannot apply, and non-U.S. components of U.S. organizations are not eligible to apply as the applicant entity. However, the announcement notes that "foreign components," as defined under the NIH Grants Policy Statement, may be allowed in some cases, which typically means a discrete element of the project can be performed outside the U.S. if it is well justified and consistent with federal policy. The core applicant, though, must be a qualifying U.S. small business with the capability to carry out the proposed R and D and manage the compliance responsibilities that come with clinical research.
As an SBIR grant mechanism, the opportunity supports small business-led innovation intended to translate into real-world use. While the solicitation text provided does not list a specific award ceiling or expected number of awards, SBIR funding generally follows a phased structure under the R43/R44 program: Phase I is commonly used to establish feasibility and early proof of concept, and Phase II is used to expand development and further validate the innovation, often including more robust clinical evaluation and steps toward regulatory and commercialization milestones. Because this parent FOA requires a clinical trial, applicants should be prepared for the operational and regulatory realities of human research, such as study design, participant protections, data and safety monitoring, and any applicable FDA regulatory considerations depending on whether the product is a drug, biologic, device, diagnostic, or digital health tool.
The funding instrument type is a grant, and the opportunity is categorized as discretionary federal funding. The activity categories tied to the CFDA listings span a wide set of health-related programs, reflecting the broad missions of NIH, CDC, and FDA. The long list of CFDA numbers indicates that many institutes and programs may participate and make awards under this umbrella, which reinforces that fit with an institute or center mission is central. Applicants are expected to align their project with the programmatic interests of one or more participating components, meaning the scientific rationale and the clinical trial should clearly map to the public health, biomedical, or regulatory science priorities of the funding organization most relevant to the work.
Key dates included in the source data show the opportunity was created on May 7, 2019, with an original closing date of July 6, 2020. Even though those dates indicate the historical window for that particular posting, the main takeaway is what the program was offering: a route for U.S. small businesses to obtain SBIR support, under NIH/CDC/FDA, for projects that are mature enough to include at least one clinical trial and that are directly tied to the mission needs and research topic areas identified in the omnibus solicitation materials.Apply for PA 19 273
- The National Institutes of Health in the education, environment, health, income security and social services sector is offering a public funding opportunity titled "PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA 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): 93.061, 93.068, 93.073, 93.084, 93.103, 93.113, 93.136, 93.143, 93.172, 93.173, 93.213, 93.233, 93.242, 93.262, 93.273, 93.279, 93.307, 93.316, 93.326, 93.351, 93.361, 93.393, 93.394, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.840, 93.855, 93.856, 93.859, 93.865, 93.866, 93.867.
- 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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FAQs: PHS 2019-02 Omnibus Solicitation (PA 19-273) - SBIR R43/R44 (Clinical Trial Required)
What is the PHS 2019-02 Omnibus Solicitation (PA 19-273)?
The PHS 2019-02 Omnibus Solicitation (PA 19-273) is a federal SBIR grant opportunity run jointly by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA). It is designed to fund U.S. small business concerns that can develop innovative products, processes, or technologies that support the research and development missions of these agencies.
Which agencies are involved in this grant opportunity?
This solicitation is operated jointly by NIH, CDC, and FDA. Applicants are expected to align their proposed project with the mission and scientific priorities of one or more participating NIH Institutes and Centers and relevant CDC or FDA components.
What is meant by an "omnibus" or "parent" solicitation?
This opportunity functions as a broad umbrella or "parent" announcement. Instead of being limited to one narrow disease area or technology focus, applicants propose projects that match the scientific priorities of participating NIH/CDC/FDA components and fall within topic areas laid out in the companion PHS 2019-2 SBIR/STTR Program Descriptions and Research Topics document.
What funding mechanism/pathway does this opportunity use?
This parent announcement uses the SBIR R43/R44 pathway. It supports small business-led research and development intended to translate into real-world products or technologies.
Is this opportunity specifically for SBIR (not STTR)?
Yes. The specific parent announcement described is the SBIR R43/R44 pathway. The topic areas are referenced in companion SBIR/STTR program descriptions, but this opportunity is explicitly identified as SBIR R43/R44.
What does "Clinical Trial Required" mean for this announcement?
"Clinical Trial Required" means the application must include at least one clinical trial as part of the proposed work. The expectation is not limited to preclinical development or bench research; the project must advance into human subjects research where an intervention is prospectively assigned and outcomes are evaluated.
Does the clinical trial have to be part of the proposed work, or can it be optional?
For this specific parent announcement, the clinical trial is a defining feature and is required. The application must include at least one clinical trial in the proposed work.
What kinds of clinical trial goals are implied by this opportunity?
Based on the description provided, agencies are looking to support small businesses ready to test safety, feasibility, performance, or early efficacy in people, typically in a way that helps move a product toward commercialization and eventual public health impact.
Who is eligible to apply?
Eligibility is restricted to U.S. small business concerns. The core applicant organization must be a qualifying U.S. small business with the capability to conduct the proposed R&D and manage compliance responsibilities associated with clinical research.
Can a foreign institution apply as the applicant?
No. Foreign institutions cannot apply, and non-U.S. components of U.S. organizations are not eligible to apply as the applicant entity.
Are any foreign activities allowed at all?
The announcement notes that "foreign components" (as defined under the NIH Grants Policy Statement) may be allowed in some cases. This generally means a discrete element of the project may be performed outside the U.S. if it is well justified and consistent with federal policy. However, the applicant must still be a qualifying U.S. small business.
What types of projects is this solicitation intended to fund?
It is intended to fund innovative products, processes, or technologies that support NIH, CDC, and FDA research and development missions. Projects should align with the scientific priorities of one or more participating components and match the topic areas in the companion SBIR/STTR Program Descriptions and Research Topics document.
How important is mission and topic alignment for an application?
Fit with an institute or center mission is central. The scientific rationale and the clinical trial should clearly map to the public health, biomedical, or regulatory science priorities of the most relevant NIH Institute/Center or CDC/FDA component for the work.
What is the funding instrument type?
The funding instrument is a grant.
How is this opportunity categorized in federal funding terms?
It is categorized as discretionary federal funding.
Does the provided information specify an award ceiling or number of awards?
No. The solicitation text provided does not list a specific award ceiling or expected number of awards.
How does the SBIR phased structure relate to R43/R44 in this opportunity?
SBIR funding generally follows a phased structure under the R43/R44 program: Phase I is commonly used to establish feasibility and early proof of concept, and Phase II is used to expand development and further validate the innovation. In this parent FOA, the work is expected to include at least one clinical trial, so applicants should be prepared for clinical research activities within the proposed phases.
What kinds of operational and compliance considerations come with the clinical trial requirement?
Applicants should be prepared for the operational and regulatory realities of human research, including study design, participant protections, data and safety monitoring, and any applicable FDA regulatory considerations depending on whether the product is a drug, biologic, device, diagnostic, or digital health tool.
Do applicants need to consider FDA-related requirements?
The description indicates that FDA regulatory considerations may apply depending on the nature of the product (for example, drug, biologic, device, diagnostic, or digital health tool). The clinical trial requirement also implies additional human-subjects and safety-related responsibilities.
What do the CFDA listings indicate about the scope of this opportunity?
The activity categories tied to the CFDA listings span a wide set of health-related programs. The long list of CFDA numbers indicates many institutes and programs may participate and make awards under this umbrella, reinforcing that the solicitation is broad and that matching to the right participating component is important.
What were the key dates for the opportunity in the source information?
The opportunity was created on May 7, 2019, and had an original closing date of July 6, 2020.
What is the main practical takeaway from the dates provided?
Even though the dates reflect the historical window for that posting, the key takeaway is the program structure: a route for U.S. small businesses to obtain SBIR support under NIH/CDC/FDA for projects mature enough to include at least one clinical trial and aligned to the missions and topic areas identified in the omnibus materials.
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Applicants who have applied for this opportunity (PA 19 273) also looked into and applied for these:
| Funding Opportunity |
|---|
| Dissemination and Implementation Research in Health (R03 Clinical Trial Not Allowed) Apply for PAR 19 276 Funding Number: PAR 19 276 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: $50,000 |
| Dissemination and Implementation Research in Health (R01 Clinical Trial Optional) Apply for PAR 19 274 Funding Number: PAR 19 274 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 20 150 Funding Number: RFA MH 20 150 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Marmoset Colonies for Neuroscience Research (U24 Clinical Trials Not Allowed) Apply for RFA MH 20 145 Funding Number: RFA MH 20 145 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| NIH Blueprint for Neuroscience Research Education Program on Translational Devices (R25 Clinical Trial Not Allowed) Apply for RFA NS 20 003 Funding Number: RFA NS 20 003 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: $250,000 |
| NIH Blueprint Program for Enhancing Neuroscience Diversity through Undergraduate Research Education Experiences (BP-ENDURE) (R25 Clinical Trial Not Allowed) Apply for RFA NS 20 015 Funding Number: RFA NS 20 015 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Clinical Trial Readiness (R21 Clinical Trial Not Allowed) Apply for RFA OD 20 004 Funding Number: RFA OD 20 004 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: $200,000 |
| Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grant (Parent T32) Apply for PA 20 142 Funding Number: PA 20 142 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required) Apply for PA 20 184 Funding Number: PA 20 184 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 20 189 Funding Number: PA 20 189 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 20 198 Funding Number: PA 20 198 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 20 204 Funding Number: PA 20 204 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 20 201 Funding Number: PA 20 201 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 20 202 Funding Number: PA 20 202 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Emergency Awards: RADx-UP Coordination and Data Collection Center (CDCC) (U24 Clinical Trial Optional) Apply for RFA OD 20 013 Funding Number: RFA OD 20 013 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Tools for Germline Gene Editing in Marmosets (U01 - Clinical Trial Not Allowed) Apply for RFA DA 21 006 Funding Number: RFA DA 21 006 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Fertility Status as a Marker for Overall Health (R01 Clinical Trial Optional) Apply for PAR 20 281 Funding Number: PAR 20 281 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Fertility Status as a Marker for Overall Health (R21 Clinical Trial Not Allowed) Apply for PAR 20 282 Funding Number: PAR 20 282 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Centers to Advance Research in Endometriosis (CARE) (P01 Clinical Trial Not Allowed) Apply for RFA HD 21 002 Funding Number: RFA HD 21 002 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: $1,000,000 |
| NIH Blueprint for Neuroscience Research: Functional Neural Circuits of Interoception (R01, Clinical Trial Not Allowed) Apply for RFA AT 21 003 Funding Number: RFA AT 21 003 Agency: National Institutes of Health Category: Education, Environment, Health, Income Security and Social Services Funding Amount: $375,000 |
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