Opportunity Information: Apply for PA 27 100
The NIH, CDC, and FDA Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Optional), Funding Opportunity Number PA-27-100, is a federal discretionary grant opportunity designed to help U.S. small businesses move promising scientific and technological innovations toward real-world commercialization. It is part of the SBIR program, which focuses on strengthening the role of small business concerns (SBCs) in federally supported research and development by funding early-stage feasibility work and then supporting the later R and D steps needed to turn an idea into a market-ready product, process, or service that improves health outcomes.
This opportunity uses the SBIR grant mechanism with two main phases: Phase I (R43) generally supports feasibility studies and early proof-of-concept work, while Phase II (R44) supports more advanced research and development aimed at producing a commercially viable product. The notice is labeled “clinical trial optional,” meaning applicants may propose projects that do not involve clinical trials, but they may also propose a clinical trial if it is appropriate for their technology and stage of development. In practice, this gives companies flexibility to propose anything from preclinical development and validation to clinical evaluation, depending on what is scientifically justified and responsive to the participating agencies’ health missions.
Eligibility is restricted to U.S. small business concerns as defined by the Small Business Administration (SBA). Only these U.S.-based SBCs can apply as the applicant organization, and the solicitation explicitly excludes non-U.S. entities from applying. It also excludes non-domestic components of U.S. organizations, which typically means the funded work under the award is not intended to be carried out by foreign branches, foreign affiliates, or other non-U.S. organizational components as part of the applicant’s setup. That said, the opportunity notes that certain unfunded international collaborations or unfunded foreign components may be allowed under NIH Grants Policy, which generally refers to situations where international partners contribute in ways that are not supported with NIH funds and are properly disclosed and justified. Applicants would still need to align with NIH policy requirements and the specific eligibility rules described in the Notice of Funding Opportunity (NOFO), especially Section III (Eligibility Information).
Administratively, the opportunity is sponsored by the National Institutes of Health (NIH), with the broader “parent” SBIR structure used across NIH and in coordination with CDC and FDA interests, and it falls under the Health funding activity category. It is associated with multiple CFDA (Assistance Listing) numbers spanning a wide range of NIH program areas, which signals that the parent announcement can be used to propose innovations relevant to many different institutes and centers rather than being limited to a single disease area or niche topic. The listed original closing date is 2027-04-05, indicating an extended window during which applications may be accepted according to the NOFO’s submission schedule and standard SBIR due dates. The posting does not specify an award ceiling or expected number of awards in the provided data, so applicants typically need to rely on the NOFO text and NIH SBIR/STTR guidance for current budget expectations, phase limits, and institute-specific considerations.
Overall, this parent SBIR clinical-trial-optional grant is a broad entry point for U.S. small businesses developing health-related innovations that can progress from feasibility through more advanced development with a clear path toward commercialization. The key takeaways are that the applicant must be a U.S. SBA-qualified small business, foreign organizations cannot apply, foreign components of U.S. organizations are not eligible for funding, and limited unfunded international collaboration may be permissible if it fits NIH policy and is properly documented in the application.Apply for PA 27 100
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIH, CDC and FDA Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Optional)" 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, 93.083, 93.084, 93.103, 93.113, 93.121, 93.136, 93.142, 93.143, 93.172, 93.173, 93.213, 93.233, 93.242, 93.273, 93.279, 93.286, 93.307, 93.313, 93.326, 93.350, 93.351, 93.361, 93.393, 93.394, 93.395, 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 2026-05-28.
- Applicants must submit their applications by 2027-04-05.
- Eligible applicants include: Small businesses.
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FAQs: NIH, CDC, and FDA Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Optional) - PA-27-100
What is the PA-27-100 Parent SBIR (R43/R44) Clinical Trial Optional opportunity?
PA-27-100 is a federal discretionary grant opportunity under the Small Business Innovation Research (SBIR) program sponsored by the National Institutes of Health (NIH), with coordination across CDC and FDA interests. It is intended to help U.S. small businesses move promising scientific and technological innovations toward real-world commercialization that improves health outcomes.
What is the main goal of this SBIR parent announcement?
The goal is to strengthen the role of U.S. small business concerns (SBCs) in federally supported research and development by funding early feasibility work and then supporting further R&D steps needed to translate an idea into a commercially viable product, process, or service relevant to health.
Which agencies are associated with this opportunity?
The opportunity is sponsored by NIH and structured as a "parent" SBIR announcement that aligns with broader CDC and FDA interests. The funding activity category is Health.
What does "Parent SBIR" mean in this context?
"Parent SBIR" indicates this is a broad, generally applicable SBIR solicitation that can be used for innovations relevant to many NIH institutes and centers (and aligned health missions), rather than being limited to one narrow topic area. The inclusion of multiple Assistance Listing (CFDA) numbers reflects that breadth.
What are the two SBIR phases referenced (R43 and R44)?
This opportunity uses the SBIR grant mechanism with two main phases:
- Phase I (R43): Generally supports feasibility studies and early proof-of-concept work.
- Phase II (R44): Supports more advanced research and development aimed at producing a commercially viable product.
What does "clinical trial optional" mean?
"Clinical trial optional" means applicants may propose projects that do not involve clinical trials, but they may also propose a clinical trial if it is appropriate for the technology and stage of development. This provides flexibility to propose preclinical development and validation, clinical evaluation, or other approaches, as scientifically justified and aligned with participating agencies' health missions.
Do projects have to include a clinical trial to be eligible?
No. The opportunity explicitly allows applications that do not involve clinical trials. A clinical trial may be proposed only if it is appropriate for the proposed technology and development stage.
Who is eligible to apply?
Eligibility is restricted to U.S. small business concerns (SBCs) as defined by the Small Business Administration (SBA). Only U.S.-based SBCs can apply as the applicant organization.
Can non-U.S. organizations apply?
No. The solicitation explicitly excludes non-U.S. entities from applying.
Are foreign components or foreign branches of a U.S. organization eligible to be funded?
No. The opportunity excludes non-domestic components of U.S. organizations from being eligible for funding. In general, this means the funded work under the award is not intended to be performed by foreign branches, foreign affiliates, or other non-U.S. organizational components as part of the applicant's setup.
Are any international collaborations allowed?
The opportunity notes that certain unfunded international collaborations or unfunded foreign components may be allowed under NIH Grants Policy. These are typically situations where international partners contribute in ways that are not supported with NIH funds and are properly disclosed and justified. Any such arrangements would need to comply with NIH policy requirements and the specific eligibility rules described in the NOFO, particularly Section III (Eligibility Information).
Where should applicants look for the detailed eligibility requirements?
Applicants should rely on the Notice of Funding Opportunity (NOFO) text for the authoritative eligibility rules and instructions, especially Section III (Eligibility Information).
What kinds of projects are a fit for this opportunity?
Based on the description provided, this parent SBIR is a broad entry point for U.S. small businesses developing health-related innovations with a clear path toward commercialization. Proposed work can range from feasibility and proof-of-concept through more advanced development, and may include clinical evaluation when appropriate.
Is this opportunity limited to a single disease area or narrow topic?
No. The association with multiple Assistance Listing (CFDA) numbers across many NIH program areas signals that it can support innovations relevant to numerous institutes and centers, rather than being restricted to one specific disease area or niche topic.
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is PA-27-100.
What is the original closing date listed for this opportunity?
The listed original closing date is 2027-04-05.
Does the posting specify the award ceiling or expected number of awards?
No. The provided information does not specify an award ceiling or an expected number of awards. Applicants are typically expected to consult the NOFO text and NIH SBIR/STTR guidance for current budget expectations, phase limits, and any institute-specific considerations.
How does this grant support commercialization?
The SBIR structure described supports commercialization by funding early-stage feasibility work (Phase I) and then supporting later R&D steps (Phase II) aimed at translating the innovation into a market-ready product, process, or service that improves health outcomes.
What are the key eligibility takeaways for applicants?
- The applicant must be a U.S. small business concern (SBC) as defined by the SBA.
- Non-U.S. entities cannot apply.
- Non-domestic components of U.S. organizations are not eligible for funding under the award.
- Limited unfunded international collaboration may be permissible if it complies with NIH Grants Policy and is properly disclosed and justified.
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