NIAID Clinical Trial Planning Grant (R34 Clinical Trial Not Allowed) | PAR 23 206

Opportunity Information: Apply for PAR 23 206

The NIAID Clinical Trial Planning Grant (R34 Clinical Trial Not Allowed), Funding Opportunity Number PAR-23-206, is a discretionary NIH grant opportunity designed to support investigators who are getting an investigator-initiated clinical trial ready to launch, but are not yet conducting the trial itself under this award. The purpose is to fund the planning, design work, and preparation of the full set of materials and documentation needed so that a future clinical trial can be implemented efficiently and rigorously. In practice, this mechanism is meant to de-risk the start-up phase of a clinical trial by paying for the front-end work that often determines whether a trial is feasible, well-designed, and compliant before enrollment ever begins.

Projects proposed under this FOA must be centered on a clinical trial concept that is hypothesis-driven and structured around clearly defined milestones. NIAID is looking for trials that fit within its scientific mission and that the Institute considers high priority, which generally aligns with infectious diseases, immunology, and allergy-related research areas. Applicants are specifically encouraged to consult NIAID program priorities and mission information on the NIAID website to ensure strong alignment with the Institute's current needs and high-priority topics (https://www.niaid.nih.gov/research/role). While the R34 supports clinical trial planning activities, the FOA explicitly indicates that the clinical trial itself is not allowed under this grant, meaning funds should be used for preparation rather than for enrolling participants or executing the intervention and follow-up.

This opportunity is offered by the National Institutes of Health (NIH) under the Health funding activity category, with CFDA number 93.855. The funding instrument type is a grant. The application is open to a wide range of eligible applicant organizations across government, academia, nonprofit, and industry settings. 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; Native American tribal organizations other than federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other qualifying entities. The FOA also highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), 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, and non-U.S. entities (foreign organizations), as well as Indian/Native American tribal governments other than federally recognized ones.

From an applicant standpoint, the key deliverable is a well-justified, milestone-driven plan that results in trial-ready documentation. That often includes finalizing the protocol and statistical analysis plan, developing operational manuals and data management plans, establishing recruitment and retention strategies, confirming site readiness, setting up trial governance and monitoring approaches, addressing regulatory and ethics needs, and preparing other materials that would be required for a subsequent clinical trial award application or for initiating the study under an appropriate mechanism. The emphasis is on producing a complete, implementable blueprint for a high-quality clinical trial that NIAID would view as aligned with its mission and priorities.

The opportunity was created on 2023-06-02, and the listed original closing date is 2026-05-13. The source information does not provide an award ceiling or an expected number of awards in the fields shown, so applicants would need to consult the full FOA text and NIH guidance for budget limits, project period expectations, and any specific NIAID programmatic requirements tied to this R34 planning mechanism.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAID Clinical Trial Planning Grant (R34 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 2023-06-02.
• Applicants must submit their applications by 2026-05-13. (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 23 206

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