Novel Genomic Technology Development (R43/R44 Clinical Trial Not Allowed) | PAR 18 779

Opportunity Information: Apply for PAR 18 779

The Novel Genomic Technology Development (R43/R44 Clinical Trial Not Allowed) opportunity, listed as PAR 18-779, is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) funding announcement designed to push genomics forward through the creation of new tools and methods. It is aimed specifically at small businesses that are developing innovative genomic technologies, with an emphasis on ideas that go beyond the development of nucleic acid sequencing technologies. In other words, the program is not looking for the next sequencing machine or incremental sequencing improvements as its main focus; it is looking for other kinds of breakthroughs across the broader genomics technology landscape that could significantly change what researchers and clinicians are able to measure, interpret, or do with genomic information.

A central theme of the FOA is novelty and impact. NIH is signaling that it wants high-risk, high-reward technology development that could meaningfully reshape genomics within roughly the next three to five years. That timeline is important because it implies a preference for technologies that are ambitious but still plausibly mature enough to demonstrate clear feasibility, strong prototypes, or compelling validation in the near term, rather than purely speculative concepts with no practical development path. The announcement is structured to support technology development work that can catalyze major advances, meaning projects should be positioned to unlock capabilities that are currently difficult, slow, expensive, or impossible with existing tools.

The funding mechanism is SBIR, using the R43/R44 activity codes, which typically align with a phased innovation pathway: Phase I (R43) focuses on feasibility and early proof-of-concept, while Phase II (R44) supports further development, refinement, and steps toward commercialization. While the details of budgets and award amounts are not provided in the source text here (the award ceiling and expected awards fields are blank), the overall intent is clearly to help small companies move promising genomic technology concepts into working products or platforms that the broader community can adopt.

The announcement is explicitly labeled "Clinical Trial Not Allowed," which sets a boundary on the kinds of studies NIH will support under this FOA. Applicants can generally conduct development and validation work, including testing performance characteristics and generating supporting data, but they cannot propose clinical trials as defined by NIH policy under this solicitation. That matters for companies operating in diagnostics or clinical genomics, because it means the work should be framed as technology development and non-trial validation rather than interventional clinical research intended to evaluate health outcomes in patients.

Eligibility is restricted to small businesses, consistent with SBIR rules. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply. At the same time, the FOA notes that "foreign components," as defined in the NIH Grants Policy Statement, may be allowed, which typically means a U.S. applicant organization can, in some circumstances, include a clearly justified portion of the project that involves a foreign collaborator, site, or resource, as long as it fits NIH policy and is appropriately approved. The practical takeaway is that the applicant entity must be a qualifying U.S. small business, and any international involvement must be handled carefully within NIH rules rather than through a foreign applicant organization.

From an administrative standpoint, the opportunity is categorized as discretionary grant funding under the health area (CFDA 93.172) and is administered by NIH. The opportunity was created on May 9, 2018, and the original closing date listed in the provided data is January 7, 2021. Even though that closing date indicates the original submission window has passed for the instance referenced, the program description captures the purpose and boundaries of the funding announcement: to stimulate major advances in genomics by backing small business-led development of novel, high-impact technologies outside the traditional sequencing-technology lane, with the expectation that funded projects could meaningfully influence the field within a few years.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Novel Genomic Technology Development (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): 93.172.
• This funding opportunity was created on 2018-05-09.
• Applicants must submit their applications by 2021-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 18 779

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