Advancing Development of Diagnostics for Congenital and Adult Acquired Syphilis (R21 Clinical Trial Not Allowed) | RFA AI 23 039

Opportunity Information: Apply for RFA AI 23 039

The funding opportunity titled "Advancing Development of Diagnostics for Congenital and Adult Acquired Syphilis (R21 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-AI-23-039) is a discretionary NIH grant aimed at accelerating progress in syphilis diagnostics. Its central purpose is to support early-stage, innovative research that either creates new diagnostic approaches or meaningfully advances existing ones for both congenital syphilis and adult-acquired syphilis. The program specifically encourages applicants to build on recent advances in Treponema pallidum basic research, while also drawing from broader innovations across infectious disease diagnostics. In practical terms, the NOFO is looking for diagnostic development work that translates newer biological insights and modern diagnostic technologies into tools that can improve detection of syphilis infections, including cases affecting newborns.

This opportunity uses the R21 mechanism, which generally supports exploratory, high-impact projects that can establish feasibility and generate strong preliminary data for later-stage development. A key constraint is that clinical trials are not allowed under this NOFO, meaning proposed activities should not be structured as clinical trial research. Instead, the emphasis is on preclinical development, assay design and optimization, analytical validation, proof-of-concept testing, and other non-clinical-trial studies that move diagnostic concepts forward toward eventual real-world use.

The awarding agency is the National Institutes of Health, and the activity category is health (CFDA/Assistance Listing number 93.855). The maximum award amount listed is $275,000 (award ceiling). While the source data notes "ExpectedAwards:" without a number provided, the core takeaway is that this is a targeted NIH funding announcement designed to spur multiple exploratory projects rather than a single large program award.

Eligibility is broad and includes many organizational types across government, academia, nonprofit, and industry. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other applicant types. The NOFO also explicitly calls out additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, Indian/Native American tribal governments other than federally recognized entities, and non-U.S. entities (foreign organizations). This wide eligibility reflects an intent to draw in diverse capabilities, including academic laboratories, diagnostic developers, community-facing organizations, and international partners where relevant.

Key dates included in the source data show the opportunity was created on 2023-06-28, with an original closing date of 2023-11-02. Overall, the opportunity is positioned as a catalyst for innovation in syphilis diagnostic development, with a clear focus on leveraging contemporary scientific advances in T. pallidum research and modern diagnostic technologies to improve detection for both congenital infections and adult-acquired disease, while staying within a non-clinical-trial scope appropriate for the R21 exploratory grant format.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Advancing Development of Diagnostics for Congenital and Adult Acquired Syphilis (R21 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): 93.855.
• This funding opportunity was created on 2023-06-28.
• Applicants must submit their applications by 2023-11-02. (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 $275,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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