Opportunity Information: Apply for PA 20 260
PHS 2020-2 is an omnibus (broad, multi-topic) SBIR funding 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 set up as a Parent SBIR announcement using the R43/R44 grant mechanisms, meaning it is intended to support early-stage innovation through a phased, milestone-driven research and development pathway. The overall goal is to bring in U.S. small businesses that have strong technical capabilities and can contribute directly to the R&D missions of NIH, CDC, and FDA components participating under this solicitation.
The opportunity is aimed specifically at eligible U.S. small business concerns (SBCs). In practical terms, it is for companies that meet the SBIR program rules for being a qualified small business and that can propose feasible R&D projects aligned with the participating agency components. Applications are expected to respond to defined SBIR/STTR topics and priorities, referenced in the PHS 2019-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA. The “omnibus” design is important because it does not focus on a single narrow problem; instead, it serves as a parent umbrella under which many health, biomedical, public health, and FDA-regulatory science related innovation topics can be proposed, as long as they fit within the missions and the listed topics.
A central restriction in this particular parent announcement is that clinical trials are not allowed. That means applicants must propose research and development that does not include a clinical trial as defined by NIH policy (for example, studies that prospectively assign human participants to interventions to evaluate effects on health-related biomedical or behavioral outcomes). Companies can still propose a wide range of preclinical work, technology development, tool building, lab validation, prototype development, and other translational activities, but they must structure the project so it stays outside the clinical trial definition and requirements.
From an eligibility standpoint, the announcement is clear that non-U.S. entities (foreign institutions) cannot apply, and non-U.S. 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. In typical NIH usage, that means a U.S. applicant organization may be able to include a discrete portion of the work performed outside the U.S. when it is well-justified (for example, a unique resource, population, specimen source, or expertise), but the applicant and awardee must still be an eligible U.S. small business and the foreign work must comply with NIH policy and approvals.
Administratively, this is a discretionary grant opportunity (not a contract), and it spans a wide set of program areas reflected by the many CFDA numbers listed (93.xxx series), which collectively cover a broad range of health and biomedical domains across NIH institutes and centers and related HHS components. The posting shows an original closing date of 2021-04-05 and a creation date of 2020-07-13, situating it within the PHS 2020-2 omnibus cycle. An award ceiling is not specified in the provided data excerpt, which is common in parent omnibus announcements because award budgets often depend on SBIR phase, topic area, institute/center policies, and the specific scope of proposed work rather than a single uniform cap.
In summary, PA 20-260 (PHS 2020-2) is a broad parent SBIR grant solicitation inviting U.S. small businesses to propose R&D projects aligned with NIH/CDC/FDA topic areas, using the SBIR R43/R44 mechanisms, with the key condition that proposed studies must not include clinical trials. It is best suited for companies developing innovative health-related technologies, products, platforms, software, diagnostics (non-clinical trial validation), research tools, and other translational capabilities that can advance federal public health and biomedical missions while remaining within the non-clinical trial scope of this announcement.Apply for PA 20 260
- 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 2020-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.068, 93.070, 93.073, 93.084, 93.103, 93.113, 93.121, 93.136, 93.172, 93.173, 93.213, 93.233, 93.242, 93.262, 93.273, 93.279, 93.286, 93.307, 93.316, 93.326, 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, 93.859, 93.865, 93.866, 93.867, 93.879.
- This funding opportunity was created on 2020-07-13.
- Applicants must submit their applications by 2021-04-05. (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 2020-2 (PA 20-260) Parent SBIR (R43/R44) - NIH/CDC/FDA (No Clinical Trials)
What is PHS 2020-2 (PA 20-260)?
PHS 2020-2 (PA 20-260) is an omnibus (broad, multi-topic) SBIR funding opportunity. It functions as a Parent SBIR announcement and is run jointly by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA).
Which agencies are involved in this funding opportunity?
This opportunity is jointly associated with NIH, CDC, and FDA components that participate under the solicitation.
What does it mean that this is an "omnibus" SBIR opportunity?
"Omnibus" means the announcement is designed as an umbrella over many possible research and development areas rather than being limited to a single narrow problem. Applicants can propose projects across a wide range of health, biomedical, public health, and FDA-regulatory science innovation topics, as long as the work aligns with participating components and the referenced topic areas.
What is a "Parent SBIR" announcement?
A Parent SBIR announcement provides a general funding pathway for SBIR proposals that fit within defined topics and agency missions. Instead of focusing on one specific initiative, it points applicants to topic descriptions and priorities that define what kinds of projects are within scope.
Which grant mechanisms does this opportunity use?
This solicitation uses the SBIR R43/R44 mechanisms, supporting a phased, milestone-driven research and development pathway for early-stage innovation.
Who is the intended applicant?
The opportunity is aimed specifically at eligible U.S. small business concerns (SBCs) that meet SBIR program rules and can propose feasible R&D aligned with participating NIH/CDC/FDA components.
Are non-U.S. organizations allowed to apply?
No. Non-U.S. entities (foreign institutions) cannot apply under this announcement.
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 as the applicant entity.
Are "foreign components" allowed at all?
Possibly. The announcement notes that "foreign components," as defined in the NIH Grants Policy Statement, may be allowed in some cases. This generally refers to a discrete portion of the work being performed outside the U.S. when it is well-justified, while the applicant and awardee remain an eligible U.S. small business and the foreign work complies with NIH policy and any required approvals.
What is the main restriction applicants need to be aware of?
Clinical trials are not allowed. Proposed R&D must be structured to stay outside the NIH definition of a clinical trial.
What does "clinical trials are not allowed" mean in practical terms?
Applicants must not propose studies that meet the NIH policy definition of a clinical trial, such as research that prospectively assigns human participants to interventions to evaluate effects on health-related biomedical or behavioral outcomes. Projects must be designed to avoid crossing into that definition and its associated requirements.
What kinds of projects are appropriate since clinical trials are not allowed?
Projects may include preclinical research, technology development, tool building, lab validation, prototype development, and other translational activities that do not meet the definition of a clinical trial. Examples described in the opportunity include innovative health-related technologies, products, platforms, software, diagnostics (with non-clinical trial validation), research tools, and related translational capabilities.
Does this opportunity focus on one topic area?
No. It is intentionally broad and supports many possible topics, as long as the proposal aligns with the missions of participating NIH/CDC/FDA components and fits within the referenced SBIR/STTR topics and priorities.
Where are the eligible topics and priorities described?
Applications are expected to respond to defined SBIR/STTR topics and priorities referenced in the PHS 2019-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA.
What is the overall goal of the solicitation?
The goal is to bring in U.S. small businesses with strong technical capabilities that can contribute directly to the R&D missions of participating NIH, CDC, and FDA components through early-stage, milestone-driven innovation.
Is this funding a grant or a contract?
This is a discretionary grant opportunity, not a contract.
Is there a single award ceiling (maximum budget) listed?
An award ceiling is not specified in the provided information. This can be typical for parent omnibus announcements because budgets often vary by SBIR phase, topic area, institute/center policies, and the scope of the proposed work.
What do the many CFDA numbers (93.xxx series) imply?
The large set of CFDA numbers indicates that the opportunity spans a wide range of program areas across NIH institutes and centers and related HHS components, reflecting broad coverage of health and biomedical domains.
What are the key dates shown for this opportunity?
The posting shows a creation date of 2020-07-13 and an original closing date of 2021-04-05, placing it within the PHS 2020-2 omnibus cycle.
How should a company decide if it is a good fit?
This opportunity is best suited for eligible U.S. small businesses proposing early-stage R&D aligned with NIH/CDC/FDA topic areas, using the SBIR R43/R44 approach, and designed specifically to avoid clinical trials while still advancing health, biomedical, public health, or FDA-regulatory science missions.
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Applicants who have applied for this opportunity (PA 20 260) also looked into and applied for these:
| Funding Opportunity |
|---|
| PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed) Apply for PA 20 265 Funding Number: PA 20 265 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Successor-in-Interest (Type 6 Parent Clinical Trial Optional) Apply for PA 20 275 Funding Number: PA 20 275 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 21 051 Funding Number: PA 21 051 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 21 050 Funding Number: PA 21 050 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 21 052 Funding Number: PA 21 052 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 21 049 Funding Number: PA 21 049 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 21 048 Funding Number: PA 21 048 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Clinical Trial Not Allowed) Apply for PAR 21 038 Funding Number: PAR 21 038 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 21 071 Funding Number: PA 21 071 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Short Courses on Innovative Methodologies and Approaches in the Behavioral and Social Sciences (R25 - Independent Clinical Trial Not Allowed) Apply for RFA OD 21 005 Funding Number: RFA OD 21 005 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $200,000 |
| Support for Research Excellence (SuRE) Award (R16 Clinical Trial Not Allowed) Apply for PAR 21 169 Funding Number: PAR 21 169 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $100,000 |
| Support for Research Excellence First Independent Research (SuRE-First) Award (R16 - Clinical Trial Not Allowed) Apply for PAR 21 173 Funding Number: PAR 21 173 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $125,000 |
| Understanding and Addressing the Impact of Structural Racism and Discrimination on Minority Health and Health Disparities (R01 Clinical Trial Optional) Apply for RFA MD 21 004 Funding Number: RFA MD 21 004 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $500,000 |
| Academic Research Enhancement Award for Undergraduate-Focused Institutions (R15 Clinical Trial Not Allowed) Apply for PAR 21 155 Funding Number: PAR 21 155 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $300,000 |
| Change of Recipient Organization (Type 7 Parent Clinical Trial Optional) Apply for PA 21 268 Funding Number: PA 21 268 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| PHS 2021-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed) Apply for PA 21 262 Funding Number: PA 21 262 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| PHS 2021-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) Apply for PA 21 259 Funding Number: PA 21 259 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| PHS 2021-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required) Apply for PA 21 260 Funding Number: PA 21 260 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 Data Coordination Center and Database (UM1 Clinical Trial Not Allowed) Apply for RFA HG 21 037 Funding Number: RFA HG 21 037 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) Clinical Trial Not Allowed Apply for RFA HG 21 036 Funding Number: RFA HG 21 036 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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