Opportunity Information: Apply for PAR 24 263
The National Institutes of Health (NIH) is offering a Small Business Innovation Research (SBIR) funding opportunity focused on bringing practical, commercial-ready innovations to population genomic screening in primary care. The program is titled "SBIR Solutions to Enable Population Genomic Screening (R43/R44 Clinical Trial Optional)" and is published as PAR-24-263. The core aim is to support small businesses developing tools, services, platforms, or workflows that make it feasible to screen broad patient populations for common and medically actionable genomic conditions as part of routine primary care, rather than limiting genomic testing to specialty settings or high-risk referrals. The emphasis on commercialization signals that NIH is looking for solutions that can realistically be adopted and sustained in real-world healthcare delivery, not just early research prototypes.
This opportunity uses the SBIR grant mechanism under the R43/R44 activity codes, which typically align with a phased development path: Phase I (R43) generally supports feasibility and proof-of-concept, while Phase II (R44) supports full research and development toward a product or service that is ready to launch or scale. The listing specifies "Clinical Trial Optional," meaning applicants may propose projects that involve clinical trial elements if appropriate for the technology or intervention, but they are not required to do so. In practical terms, this gives companies flexibility to propose anything from non-clinical development (such as software, decision-support, laboratory workflow innovation, implementation tools, or operational infrastructure) to prospective evaluation in clinical settings when needed to demonstrate performance, usability, effectiveness, or integration into care.
The program sits within NIH's health research funding category and is associated with CFDA number 93.172. Awards are competitive, and while an "expected awards" count is not provided in the summary data, the award ceiling listed is $400,000, indicating the maximum funding level referenced in the public synopsis for at least part of the award structure (often tied to Phase I budgets, though actual allowable amounts can depend on FOA-specific guidance and NIH SBIR policy). The opportunity is categorized as discretionary and uses the grant funding instrument, consistent with typical NIH SBIR solicitations.
Eligibility is limited to U.S. small businesses that meet SBIR requirements. Foreign organizations are explicitly not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply. However, the notice indicates that "foreign components" as defined by the NIH Grants Policy Statement may be allowed in some circumstances. In NIH terms, that generally means certain project elements could potentially be carried out outside the United States when there is a strong justification (for example, unique resources, populations, or expertise), but the applicant organization itself must remain a compliant U.S. small business and the use of any foreign component must follow NIH rules and obtain appropriate approval.
Key logistical details from the synopsis include the original closing date of December 2, 2024, and a creation date of August 16, 2024. The sponsoring agency is the National Institutes of Health. Overall, the opportunity is designed to help small companies bridge the gap between genomic science and everyday primary care by supporting innovations that can enable large-scale screening for actionable genetic risks, ideally in ways that are cost-effective, implementable, and ready to move toward widespread adoption.Apply for PAR 24 263
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "SBIR Solutions to Enable Population Genomic Screening (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): 93.172.
- This funding opportunity was created on 2024-08-16.
- Applicants must submit their applications by 2024-12-02. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $400,000.00 in funding.
- Eligible applicants include: Small businesses.
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FAQs: SBIR Solutions to Enable Population Genomic Screening (PAR-24-263)
What is this funding opportunity?
This is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) funding opportunity titled "SBIR Solutions to Enable Population Genomic Screening (R43/R44 Clinical Trial Optional)." The Funding Opportunity Announcement (FOA) number is PAR-24-263.
What is the main goal of PAR-24-263?
The core goal is to support small businesses in developing practical, commercial-ready innovations that make population genomic screening feasible in routine primary care settings. The focus is on enabling broad screening for common and medically actionable genomic conditions, rather than limiting testing to specialty clinics or only high-risk referrals.
What kinds of solutions is NIH looking to fund?
NIH is looking for tools, services, platforms, and workflows that help integrate population genomic screening into primary care. The synopsis indicates projects may include items such as software, decision-support, laboratory workflow innovations, implementation tools, and operational infrastructure that supports screening at scale.
Is commercialization important for this program?
Yes. The opportunity emphasizes commercialization, meaning NIH is looking for solutions that can realistically be adopted, implemented, and sustained in real-world healthcare delivery, not only early-stage research prototypes.
What grant mechanism does this opportunity use?
This opportunity uses the NIH SBIR grant mechanism under the R43/R44 activity codes.
How do R43 and R44 phases typically differ?
R43 (Phase I) generally supports feasibility and proof-of-concept work. R44 (Phase II) generally supports full research and development aimed at a product or service that is ready to launch, scale, or move toward commercialization.
Are clinical trials required under this FOA?
No. The FOA is labeled "Clinical Trial Optional," which means applicants may propose clinical trial elements if they are appropriate for the technology or intervention, but a clinical trial is not required.
If clinical trials are optional, what types of project activities might still fit?
Based on the synopsis, projects can range from non-clinical development (for example, software development, decision support, workflow tools, or operational infrastructure) to prospective evaluation in clinical settings when needed to demonstrate performance, usability, effectiveness, or integration into routine care.
Who is eligible to apply?
Eligibility is limited to U.S. small businesses that meet SBIR requirements.
Can foreign organizations apply?
No. Foreign organizations are explicitly not eligible to apply.
Are non-U.S. components of U.S. organizations eligible to apply?
No. The synopsis indicates that non-U.S. components of U.S. organizations are not eligible to apply.
Are any foreign components allowed at all?
The synopsis notes that "foreign components," as defined by the NIH Grants Policy Statement, may be allowed in some circumstances. In general NIH usage, this means certain project elements could potentially be conducted outside the United States when strongly justified (for example, due to unique resources, populations, or expertise), while the applicant organization must still be a compliant U.S. small business and must follow NIH rules and approvals for any foreign component.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.172.
What is the award ceiling mentioned in the synopsis?
The public synopsis lists an award ceiling of $400,000, which is the maximum funding level referenced in the summary. The synopsis also notes that actual allowable amounts can depend on FOA-specific guidance and NIH SBIR policy.
How many awards will NIH make?
The synopsis does not provide an expected number of awards.
Is this a discretionary grant?
Yes. The opportunity is categorized as discretionary and uses the grant funding instrument.
Which federal agency is sponsoring this opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What is the original closing date listed for this opportunity?
The synopsis lists the original closing date as December 2, 2024.
What is the creation date listed in the synopsis?
The synopsis lists a creation date of August 16, 2024.
What healthcare setting is the program trying to impact?
The program is specifically aimed at primary care, with the goal of making genomic screening a feasible part of routine care for broad patient populations.
What is meant by "population genomic screening" in the context provided?
In this synopsis, it refers to screening broad patient populations for common and medically actionable genomic conditions, rather than restricting genomic testing to specialty settings or only patients identified through high-risk referral pathways.
What is the overarching problem NIH is trying to solve with this program?
The opportunity is designed to help small companies bridge the gap between genomic science and everyday primary care by enabling large-scale screening for actionable genetic risks in ways that are cost-effective, implementable, and positioned for widespread adoption.
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