Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Clinical Trial Not Allowed)

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Description

This opportunity supports Early Stage Investigators (ESIs) seeking to launch innovative research projects that represent a significant change in their research direction, for which no preliminary data exist. The program is designed to encourage bold, high-impact ideas by removing the requirement for preliminary data, thereby enabling ESIs to pursue new scientific directions that may be higher risk but have the potential for transformative impact. The proposed research must be distinct from the applicant’s prior work and not an incremental extension of previous research.

Applications must not include any preliminary data (unpublished or published by the applicant in the new direction). Instead, the rationale for the project should be supported by published data or preprints (with DOIs) from the broader scientific community. A separate, one-page attachment is required to describe how the project represents a change in research direction for the ESI.

Clinical trials are not allowed under this funding opportunity.

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Due Dates

• Upcoming deadlines:

  • May 28, 2025 (New applications)
  • June 26, 2025 (Renewal/Resubmission/Revision)
  • August 26, 2025 (AIDS-related applications)
  • September 26, 2025 (New applications)
  • October 28, 2025 (Renewal/Resubmission/Revision)
  • December 28, 2025 (AIDS-related applications)
  • Additional cycles continue through December 2026.

• All applications are due by 5:00 PM local time of the applicant organization.

• Expiration date: December 29, 2026

See full schedule and details

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Funding Amount

• Budget: No specific budget cap; budgets must be well-justified and reflect the actual needs of the proposed project.
• Project period: Up to 5 years.
• Number of awards: Contingent on NIH appropriations and the number of meritorious applications.

Applicants requesting $500,000 or more in direct costs in any year must contact a Scientific/Research Contact at least 6 weeks before submission.

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Eligibility

• Eligible applicants include:

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

• Principal Investigator requirements:

  • Must be designated as an Early Stage Investigator (ESI) by NIH at the time of application.
  • For multiple PD/PI applications, all must be ESIs and the project must represent a change in direction for each.

• Ineligible:

  • Non-U.S. (foreign) organizations and non-U.S. components of U.S. organizations.
  • Foreign components (as defined by NIH) are allowed within U.S. organizations.

Full eligibility details

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Application Process

• Submission: Applications must be submitted electronically via Grants.gov using ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.
• Required registrations: Applicant organizations must be registered with SAM, eRA Commons, and Grants.gov. All PDs/PIs must have an eRA Commons account.
• Application instructions: Follow the NIH SF424 (R&R) Application Guide and the specific instructions in the funding announcement.
• Key attachments:
  • New Research Direction (required): A one-page PDF attachment describing how the proposed research is a change in direction from prior work. For multiple PD/PIs, one page per investigator.
  • No preliminary data: Applications must not include any preliminary data. Applications with preliminary data will be withdrawn without review.
  • Data Management and Sharing Plan: Required for all applications.
• Budget: No cap, but must be justified. Use R&R Budget Form (not modular) if requesting over $250,000/year.
• Other requirements:
  • If requesting $500,000 or more in direct costs in any year, contact a program officer at least 6 weeks before submission.
  • Follow all NIH policies on human subjects, vertebrate animals, and other compliance areas as applicable.

Full application instructions

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Additional Information

• Scope: Projects must be within the scientific mission of at least one participating NIH Institute or Center. Applicants are strongly encouraged to consult the Table of IC-Specific Information, Requirements, and Staff Contacts to ensure alignment.
• Review criteria: Emphasis on innovation, significance, and the potential for high impact. The absence of preliminary data is expected and will not be penalized.
• Resubmissions: Allowed; must address prior review comments.
• Clinical trials: Not allowed under this opportunity.
• FAQs and program information: Katz Award Program Website

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External Links

• Full Funding Announcement (PAR-24-075)
• NIH Katz Award Program Website
• Table of IC-Specific Information, Requirements, and Staff Contacts
• NIH SF424 (R&R) Application Guide
• Apply via Grants.gov

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Contact Information

For institute-specific questions, consult the Table of IC-Specific Information, Requirements, and Staff Contacts.