NIAID Investigator Initiated Program Project Applications (P01 Clinical Trial Not Allowed)

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Description

This opportunity invites investigator-initiated Program Project (P01) applications to the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. The program is designed to support integrated, multi-project research programs that address scientific areas relevant to the NIAID mission, including:

• Biology and pathogenesis of infectious microbes (including HIV)
• Host-microbe interactions
• Mechanisms regulating immune system development and function across the lifespan and in response to infectious pathogens
• Immune dysfunction (allergy, asthma, autoimmunity, immunodeficiency, transplant rejection)
• Translational research for vaccines, therapeutics, and diagnostics for infectious and immune-mediated diseases

Each application must include at least two related, synergistic research projects sharing a common central theme, focus, and/or overall objective, plus an administrative core. Optional scientific cores may be included if needed. The program emphasizes synergy—projects must be interrelated such that their combined outcomes exceed what could be achieved independently.

Clinical trials are not allowed under this FOA, but analyses of samples from independently funded clinical trials are permitted.

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Due Dates

• Standard Application Due Dates:
  • June 11, 2025 (non-AIDS applications)
  • May 7, 2025 and September 7, 2025 (AIDS and AIDS-related applications)
• Future Cycles:
  • January and June annually through September 2025 (see full schedule)
• All applications are due by 5:00 PM local time of the applicant organization.

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Funding Amount

• Budget: No specific budget cap; budgets must reflect the actual needs of the proposed project.
• Project Period: Maximum of 5 years.
• Number of Awards: Contingent on NIH appropriations and the number of meritorious applications.

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Eligibility

Eligible organizations include:

• Public and private institutions of higher education (including HBCUs, Hispanic-serving, Tribal, and AANAPISI institutions)
• Nonprofits with or without 501(c)(3) status (other than higher education)
• For-profit organizations (including small businesses)
• State, county, city, township, and special district governments
• Native American tribal governments and organizations (federally recognized and other)
• Independent school districts
• Public housing authorities/Indian housing authorities
• Faith-based and community-based organizations
• Regional organizations
• U.S. territories and possessions
• Eligible agencies of the federal government

Note:

• Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply.
• Foreign components, as defined in the NIH Grants Policy Statement, are allowed within U.S. applications.

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Application Process

• Submission: Applications must be submitted electronically via NIH ASSIST or an institutional system-to-system solution through Grants.gov.

• Instructions: Follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide and the program-specific instructions in the FOA.

• Required Components:

  • Overall component
  • Administrative core (required; only one)
  • At least two research projects (each led by an independent investigator)
  • Optional scientific cores (if needed; each must serve at least two projects)

• Page Limits:

  • Overall: 12 pages (Research Strategy)
  • Admin Core: 6 pages
  • Scientific Core: 6 pages
  • Each Project: 12 pages

• Data Management and Sharing Plan: Required in the Overall component.

• Prior Consultation: Strongly encouraged to consult with NIAID staff at least 15 weeks before the due date, especially for applications requesting $500,000 or more in direct costs in any year (excluding consortium F&A).

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Additional Information

• Synergy Requirement: Projects must be interrelated and synergistic, with clear advantages to being conducted as a program rather than as separate projects.
• No Clinical Trials: Applications proposing clinical trials will not be reviewed or funded.
• Review Criteria: Emphasis on significance, innovation, approach, investigator(s), environment, and especially the synergy among projects and cores.
• Data Sharing: All applications must address a data management and sharing plan; NIAID may require data sharing via ImmPort or other public repositories.
• Appendix: Only limited items are allowed; see FOA for details.

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External Links

• Full FOA and Application Instructions (NIH PAR-22-225)
• NIAID Mission and Research Areas
• NIAID Multiproject Application Guidance
• NIH Multi-Project Application Guide (Forms-H)
• NIH Data Management and Sharing Policy
• ImmPort Data Repository
• Frequently Asked Questions for NIAID P01

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Contact Information

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See Also

• Grants.gov Opportunity Listing
• NIH Guide to Grants and Contracts
• NIH Grants Policy Statement