Technology Development for Single-Molecule Protein Sequencing (R43/R44 Clinical Trial not allowed) | PAR 21 247

Opportunity Information: Apply for PAR 21 247

The National Institutes of Health (NIH) funding opportunity titled "Technology Development for Single-Molecule Protein Sequencing (R43/R44 Clinical Trial not allowed)" (Funding Opportunity Number PAR-21-247) is a discretionary grant program aimed at small businesses under the SBIR mechanism. Its central purpose is to drive major technology development advances that make single-molecule protein sequencing practical and routine, not just as a proof-of-concept tool but as a broadly usable platform for genome biology, functional biology, and biomedical research. The initiative is framed around accelerating progress over roughly a five-year horizon, with an emphasis on pushing beyond incremental improvements and toward breakthroughs that meaningfully change what researchers can measure and how widely they can measure it.

The scientific focus is on enabling the generation of protein sequencing data at a level of scale, speed, cost, and accuracy that supports everyday use in research settings. In practical terms, the FOA is looking for technology innovations that would allow protein sequencing to be performed in ways comparable in usefulness to modern DNA sequencing: high-throughput, reliable, and affordable enough to be integrated into large studies. The solicitation is explicitly centered on technology development for single-molecule protein sequencing, which implies an interest in methods that can read protein sequences from individual molecules rather than bulk ensembles. That typically aligns with approaches that aim to capture proteoform diversity, reduce ambiguity from averaging, and potentially enable detection of rare species, modifications, or heterogeneous samples that are difficult to resolve using conventional proteomics workflows.

This opportunity uses the NIH R43/R44 structure, meaning it supports the typical phased small business pathway where early-stage feasibility and prototype development can be pursued (Phase I, R43) followed by more advanced development and validation work (Phase II, R44). The FOA also specifies "Clinical Trial not allowed," which signals that applicants must keep the proposed work in the technology development and non-clinical evaluation space rather than designing or conducting studies that meet NIH's definition of a clinical trial. Projects can still be highly biomedical and can involve clinically relevant samples or contexts, but they must not cross into interventional clinical trial territory as defined by NIH policy.

Eligibility is limited to small businesses, consistent with SBIR/STTR-style objectives of translating innovative concepts into usable products and platforms. The notice is also explicit about foreign participation restrictions: non-U.S. (non-domestic) entities and foreign institutions are not eligible to apply, and non-domestic components of U.S. organizations are 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. In practice, this usually means the applicant organization must be U.S.-based and eligible, but certain well-justified elements of the work may be performed abroad under NIH rules if they qualify as a foreign component and are appropriately justified, disclosed, and approved.

From an administrative standpoint, the sponsoring agency is NIH, and the funding activity category is listed under education and health, reflecting the biomedical research and workforce/innovation ecosystem NIH supports. Multiple CFDA numbers are associated with this announcement (93.172, 93.393, 93.394, 93.395, 93.396, 93.399, 93.855), which typically indicates involvement or relevance across multiple NIH institutes, centers, or program areas. The opportunity was created on 2021-07-12, and the original closing date listed in the source data is 2023-06-15. The provided source data does not specify an award ceiling or expected number of awards, which usually means applicants should consult the full FOA text and related NIH guidance for budget constraints typical to R43/R44 mechanisms and any institute-specific considerations.

Overall, this FOA is best read as a targeted push to move single-molecule protein sequencing from an emerging concept into a robust, scalable technology platform. NIH is signaling that the field needs enabling innovations that reduce barriers to routine use, including improvements that increase throughput, lower per-sample costs, speed up data generation, and improve accuracy to a level that supports real biological discovery and broader adoption. The intended outcome is not simply a new assay, but a step-change in capability that makes protein sequencing data a standard, widely accessible input for studies of genome function and for biomedical research more broadly.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Technology Development for Single-Molecule Protein Sequencing (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, 93.393, 93.394, 93.395, 93.396, 93.399, 93.855.
• This funding opportunity was created on 2021-07-12.
• Applicants must submit their applications by 2023-06-15. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 21 247

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