Exploratory Data Science Methods and Algorithm Development in Infectious and Immune-mediated Diseases (R21 Clinical Trial Not Allowed) | RFA AI 21 035

Opportunity Information: Apply for RFA AI 21 035

The grant opportunity titled "Exploratory Data Science Methods and Algorithm Development in Infectious and Immune-mediated Diseases (R21 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-AI-21-035) is a discretionary NIH research grant run through the Department of Health and Human Services, National Institutes of Health, aligned with the mission of NIAID. It is designed to fund early-stage, exploratory work that pushes forward new data science, biomedical computing, and informatics methods specifically aimed at infectious diseases, emerging infections, and immune-mediated diseases. In this context, immune-mediated diseases explicitly include areas such as allergy, autoimmunity, and immune complications related to transplantation. The emphasis is not on incremental software updates or routine analytics, but on method and algorithm development that could meaningfully change what researchers can do with complex biomedical data across this research continuum.

This FOA sits under NIAID's trans-institute Data Science program (AI-DS), which signals a strong interest in next-generation computational approaches, including artificial intelligence and machine learning, but not limited to those. Competitive projects under this announcement would typically propose new computational, mathematical, or statistical algorithms and frameworks that improve how relevant biomedical data and knowledge are acquired, managed, analyzed, integrated, interpreted, and shared. In other words, the target is foundational or enabling innovations that can unlock better discovery or decision-making in NIAID priority areas, whether by making analyses more accurate, more scalable, more interpretable, more robust to noise and bias, or easier to reproduce and disseminate.

The mechanism is an R21, which is NIH's exploratory and developmental grant format. That generally means the work is expected to be high-risk/high-reward and positioned to generate proof-of-concept results, prototypes, or preliminary evidence that a new computational approach is feasible and valuable. A key restriction is embedded in the title: clinical trials are not allowed. Applicants need to ensure the proposed activities do not cross into clinical trial territory, keeping the focus on method development, computational validation, and research-oriented demonstrations rather than prospective interventional studies in humans.

From a funding standpoint, the award ceiling is listed at $200,000, with an expected number of about 4 awards. That combination suggests a relatively selective competition intended to seed a small set of especially promising ideas rather than fund a large portfolio. The opportunity was created March 17, 2021, with an original closing date of July 6, 2023, so it is time-bounded and tied to that solicitation window.

Eligibility is broad and includes many types of organizations that commonly apply to NIH: public and private institutions of higher education, nonprofit organizations (both 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses), small businesses, and a range of government entities (state, county, city/township, special districts), along with independent school districts. It also includes Native American tribal governments (federally recognized), tribal organizations that are not federally recognized governments, and public housing authorities/Indian housing authorities, plus "other" applicants as clarified in the FOA text. In practice, this wide eligibility is meant to attract interdisciplinary teams, including academic researchers, nonprofit research groups, and industry developers who can build and validate advanced computational methods relevant to NIAID priorities.

Overall, this FOA is best understood as a call for innovative, exploratory algorithmic and data-science advances that can strengthen infectious and immune-mediated disease research. The strongest applications would typically articulate a clear unmet need in the field, propose a genuinely novel methodological approach, and describe how the resulting method or prototype would substantially improve the way relevant data or knowledge are handled, analyzed, or shared, all while staying outside the scope of clinical trials.

• The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Exploratory Data Science Methods and Algorithm Development in Infectious and Immune-mediated Diseases (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 Mar 17, 2021.
• Applicants must submit their applications by Jul 06, 2023. (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 $200,000.00 in funding.
• The number of recipients for this funding is limited to 4 candidate(s).
• 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 (see text field entitled Additional Information on Eligibility for clarification).

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