NIAID Clinical Trial Planning Grant (R34 Clinical Trial Not Allowed) | PAR 19 281

Opportunity Information: Apply for PAR 19 281

The NIAID Clinical Trial Planning Grant (R34 Clinical Trial Not Allowed), Funding Opportunity Number PAR 19 281, is a discretionary NIH grant opportunity from the National Institute of Allergy and Infectious Diseases (NIAID) that supports the up-front work needed to get an investigator-initiated clinical trial fully ready to launch. The purpose is not to run a clinical trial under this award, but to fund the complete planning and design phase so investigators can produce the core deliverables and documentation required for implementation later under a separate mechanism. In practice, this means the grant is intended to help teams move a high-priority, hypothesis-driven clinical trial concept from an idea to an operationally executable trial package.

This FOA is specifically aimed at clinical trials that fit NIAID's research mission and are considered high priority by the Institute. NIAID focuses on infectious diseases, immunology, and allergy-related research, and applicants are encouraged to review NIAID's mission and priority research areas on the Institute website to ensure alignment. The trials envisioned should be hypothesis-driven and milestone-defined, meaning the application should clearly state the scientific question being tested and lay out measurable planning milestones and decision points that demonstrate progress toward a trial that is ready to start. The emphasis on milestones signals that NIAID expects structured project management during the planning period, with tangible outputs rather than exploratory or open-ended activities.

Because this is a planning grant, the supported activities generally revolve around building the trial blueprint and assembling the trial readiness documentation. That typically includes finalizing the study design (such as intervention details, control conditions, randomization approach, blinding strategy if applicable, endpoint selection, and statistical analysis plan), developing the protocol and manual of operations, establishing data management and quality assurance procedures, preparing regulatory and ethics submission materials, and setting up operational plans for recruitment, retention, safety monitoring, and multi-site coordination when relevant. The end result NIAID is looking for is a complete, well-justified trial plan that can be implemented efficiently and credibly when a future trial implementation award is pursued.

The award is categorized under Health and corresponds to CFDA number 93.855. The funding instrument is a grant, and the listed award ceiling is $150,000. The opportunity was created on 2019-05-15 and had an original closing date of 2020-08-05, indicating it was issued during that period; anyone interested would need to confirm whether the FOA is still active or has been reissued in an updated form.

Eligibility is broad and includes many types of domestic and certain non-domestic organizations. 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; tribal organizations that are not federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (when not an institution of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly notes additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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, non-domestic (non-U.S.) entities (foreign organizations), and U.S. territories or possessions. This wide eligibility reflects NIAID's interest in enabling strong trial planning efforts across academic, government, community, and international contexts where appropriate.

The key practical takeaway is that this R34 opportunity is meant to de-risk and professionalize the early stages of an investigator-initiated clinical trial by paying for the intensive planning work that is often required before a trial can responsibly begin. Applicants are expected to propose a clear, prioritized clinical trial concept aligned with NIAID's mission, then use the R34 period to produce a complete and implementation-ready trial package, guided by explicit milestones, while not conducting the clinical trial itself under this award.

• 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 2019-05-15.
• Applicants must submit their applications by 2020-08-05. (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 $150,000.00 in funding.
• 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 19 281

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