SBIR Solutions to Enable Population Genomic Screening (R43/R44 Clinical Trial Optional) | PAR 24 263

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.

• 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.

Apply for PAR 24 263

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