NIAID Investigator Initiated Program Project Applications (P01 Clinical Trial Not Allowed) | PAR 22 225

Opportunity Information: Apply for PAR 22 225

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is soliciting investigator-initiated Program Project Grant (P01) applications under FOA number PAR-22-225. This is a discretionary grant opportunity in the health area (CFDA 93.855) that supports large, integrated research programs rather than single, stand-alone projects. The program is designed for teams that can organize multiple related research efforts around one unifying scientific theme and show that the combined approach will produce greater impact than the projects would achieve independently.

The scientific scope is broad but anchored firmly in NIAIDs mission areas. Proposed programs should address important questions in the biology and pathogenesis of infectious microbes, explicitly including HIV, and should consider host-microbe interactions where relevant. Applications may also focus on mechanisms that regulate immune system development and immune function across the lifespan, including immune responses to infectious pathogens. Another major emphasis is on immune dysfunction and immune-mediated disease, such as allergy, asthma, autoimmunity, immunodeficiency, and transplant rejection, particularly when these conditions relate to infection-driven or immune-driven mechanisms. In addition to basic and mechanistic research, the FOA welcomes translational work aimed at developing vaccines, therapeutics, and diagnostics that prevent, treat, or help manage infectious and immune-mediated diseases.

Structurally, every application must include at least two scientifically related and synergistic research projects. These projects need to be tightly connected by a shared central theme, common focus, and/or an overall objective that ties the program together in a cohesive way. The FOA also requires an Administrative Core, reflecting the expectation that a P01 functions as a coordinated program with shared governance, management, communication plans, and resource oversight. Scientific Cores are optional and can be included when they provide essential shared services, technologies, or resources that improve efficiency, standardize methods, or strengthen integration across the projects. The overall expectation is that the program demonstrates real interdependence, such as shared aims, complementary expertise, shared datasets or platforms, or coordinated experimental strategies, rather than simply bundling separate projects under one umbrella.

Clinical trials are not allowed under this announcement, meaning the proposed work must avoid NIH-defined clinical trial activities. Applicants typically need to ensure that any human-related components do not meet the NIH definition of a clinical trial, and that the research plan aligns with the non-clinical-trial requirements of this FOA.

Eligibility includes a wide range of domestic organization types and government entities. Eligible applicants include state, county, city or township, and 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; and Native American tribal organizations that are not federally recognized tribal governments. The FOA also allows public housing authorities/Indian housing authorities, nonprofits with or without 501(c)(3) status (other than institutions of higher education), for-profit organizations (other than small businesses), and small businesses. It also explicitly highlights a variety of mission-relevant and capacity-building institution types as eligible, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

Foreign eligibility is restricted in a specific way. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, which generally means a U.S.-based applicant may include certain well-justified foreign collaborations or performance sites when they are essential to the science and meet NIH policy requirements.

Key administrative details provided in the listing include an original closing date of 2025-09-07 and a creation date of 2022-09-13. The award ceiling and expected number of awards are not specified in the provided data, which is common for NIH FOAs where budget and award counts depend on scientific merit, program priorities, and available appropriations.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAID Investigator Initiated Program Project Applications (P01 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 2022-09-13.
• Applicants must submit their applications by 2025-09-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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.

Apply for PAR 22 225

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: