Small Business Informatics Tools for the Pangenome (R43 Clinical Trial Not Allowed) | PAR 25 308

Frequently Asked Questions (FAQs)

What is this funding opportunity?

This is an NIH Small Business Innovation Research (SBIR) Phase I funding opportunity (R43) offered through the National Human Genome Research Institute (NHGRI). It is focused on building practical informatics tools that help the broader genomics community use the human pangenome reference in real-world research and clinical-adjacent settings.

Which NIH institute is sponsoring this, and what program is it tied to?

The opportunity is offered by NHGRI and is tied to the Human Genome Reference Program (HGRP), which maintains the human pangenome reference effort.

What is the program announcement number?

The program announcement is PAR 25-308.

What is the overall goal of the human pangenome reference?

The pangenome reference aims to provide a richer and more representative genomic reference than the traditional single linear reference by better capturing human genetic diversity.

What kinds of projects is NIH looking to fund under this announcement?

The announcement seeks Phase I SBIR projects that translate the pangenome reference into usable software, workflows, and computational methods that scientists and clinicians can adopt. The emphasis is on reducing friction in accessing, analyzing, interpreting, visualizing, and integrating pangenome-based references into existing genomics pipelines.

Is this opportunity only for informatics and software, or can it include other work?

Based on the description provided, the focus is on informatics tools: software, workflows, and computational methods intended to make pangenome resources easier to use and integrate. The central theme is practical, commercially viable tooling rather than producing the reference itself.

What does "Phase I (R43) SBIR" mean in this context?

This opportunity is specifically for Phase I SBIR projects, which are geared toward proof-of-concept work. Applicants are expected to demonstrate early feasibility or proof of principle for a proposed tool, not to deliver a fully mature product in Phase I.

Are applicants expected to deliver a finished product by the end of Phase I?

No. The emphasis is on proof-of-concept and early feasibility. A competitive Phase I application would typically propose credible technical milestones that demonstrate the approach works and that it can plausibly be developed into a usable product.

What problem is this funding trying to solve?

The program is trying to reduce the barriers and day-to-day friction researchers face when using pangenome-based references, and to accelerate scientific uptake by enabling easier access, analysis, interpretation, visualization, and pipeline integration.

What are examples of strong use cases mentioned for proposed tools?

The opportunity highlights use cases that matter across the genomics ecosystem, including:

• Clinical genomics (for example, variant interpretation or diagnostic workflows)
• Population genomics (for example, ancestry-aware analyses or studies of diverse cohorts)
• Functional genomics (for example, linking variation to regulatory function or gene expression)

Who is eligible to apply?

Only eligible U.S. small business concerns can apply.

Are foreign (non-U.S.) organizations eligible to apply?

No. Foreign (non-U.S.) organizations are not eligible to apply as applicants under this opportunity.

Can a U.S. small business apply if part of the organization is outside the U.S.?

Non-U.S. components of U.S. organizations are not eligible to apply as applicants. However, foreign components (as defined under NIH policy) may be allowed in some circumstances if adequately justified and permitted under NIH rules, while the applying entity remains an eligible U.S. small business.

Does this opportunity allow any work to be performed outside the United States?

Potentially, yes, but only in limited circumstances. The description notes that foreign components as defined under NIH policy may be allowed in some cases if justified and permitted, while the applicant must still be an eligible U.S. small business.

Is this a discretionary grant program, and how is it classified?

Yes. It is described as a discretionary grant program under NIH and is associated with a health-related funding activity classification (CFDA 93.172).

What is the award ceiling?

The listed award ceiling is $400,000, indicating the approximate maximum expected budget level for an award under this announcement.

When was this opportunity created, and when does it close?

The opportunity was created on December 10, 2024. The original closing date is March 3, 2025.

Are clinical trials allowed under this funding opportunity?

No. This is labeled "Clinical Trial Not Allowed," meaning applicants should not propose a study that meets NIH's definition of a clinical trial. The work should remain focused on tool development and validation rather than prospective clinical testing of an intervention in humans.

Can proposed projects involve clinical genomics use cases if clinical trials are not allowed?

Yes. Clinical genomics use cases are explicitly mentioned (such as variant interpretation or diagnostic workflows). The key constraint is that the project should not propose a study that meets NIH's definition of a clinical trial; it should focus on tool development and validation.

What types of capabilities are specifically encouraged for pangenome tools?

The description emphasizes tools that make pangenome data easier to access, analyze, interpret, visualize, and integrate into existing genomics pipelines.

What makes an application likely to be competitive, based on the description provided?

Competitive applications will likely do the following:

• Identify a clear gap in current pangenome tooling
• Explain why that gap is a barrier to adoption
• Propose an innovative informatics approach
• Provide a credible Phase I technical plan with milestones
• Include compelling use cases with clear real-world users
• Show a plausible commercialization direction consistent with SBIR goals

Why does commercialization matter for this opportunity?

This is an SBIR opportunity, which is designed to support small businesses developing products or services that can ultimately be sustained in the marketplace. The announcement stresses practical, commercially viable tools and an obvious pathway to real users.

Is the goal to build the pangenome reference itself?

No. The stated aim is to translate the pangenome reference resource into usable tools, workflows, and computational methods that enable broader adoption and easier practical use.

What stage of development is the NIH trying to fund here?

Phase I proof-of-concept: early feasibility and proof of principle for a proposed tool, with a focus on demonstrating that the technical approach works and can support later development toward real-world adoption.