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.Apply for PAR 19 281
- 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.
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FAQs: NIAID Clinical Trial Planning Grant (R34 Clinical Trial Not Allowed) - PAR 19-281
What is the NIAID Clinical Trial Planning Grant (R34 Clinical Trial Not Allowed) for?
This discretionary NIH grant opportunity from the National Institute of Allergy and Infectious Diseases (NIAID) supports the up-front work required to get an investigator-initiated clinical trial fully ready to launch. The award is meant to fund the complete planning and design phase so the project team can produce the key deliverables and documentation needed for later implementation under a separate funding mechanism.
Does this R34 award fund the actual conduct of a clinical trial?
No. The purpose of this FOA is planning and design only. The clinical trial itself is not intended to be conducted under this award. The expectation is that planning outputs will support a future, separate application for trial implementation funding.
What does "Clinical Trial Not Allowed" mean in this opportunity?
Based on the information provided, it indicates the award is for clinical trial planning activities rather than running the clinical trial during the R34 project period.
What is the Funding Opportunity Number (FOA) for this grant?
The Funding Opportunity Number listed is PAR 19-281, titled the NIAID Clinical Trial Planning Grant (R34 Clinical Trial Not Allowed).
Which NIH Institute is offering this opportunity?
The opportunity is offered by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
What kinds of research areas does NIAID prioritize for this planning grant?
The FOA is aimed at clinical trials that fit NIAID's mission and are considered high priority by the Institute. NIAID focuses on infectious diseases, immunology, and allergy-related research. Applicants are encouraged to review NIAID's mission and priority research areas to confirm alignment.
What type of clinical trial concept is this FOA looking for?
The trials envisioned should be hypothesis-driven and considered high priority by NIAID. Applications should clearly state the scientific question being tested and present a structured plan that results in a trial package ready to implement later.
What does "milestone-defined" mean in the context of this R34 planning grant?
It means the application should lay out measurable planning milestones and decision points that demonstrate progress toward a clinical trial that is ready to start. The emphasis is on structured project management and tangible outputs rather than open-ended or exploratory work.
What activities can this planning grant support?
Supported activities generally focus on creating the trial blueprint and trial readiness documentation. Examples described include finalizing the study design, developing key documents, and preparing operational and regulatory materials that would be needed before implementation.
What study design elements might be finalized during the R34 planning period?
Based on the description, planning activities may include intervention details, control conditions, randomization approach, blinding strategy (if applicable), endpoint selection, and development of the statistical analysis plan.
What documents and deliverables is NIAID looking for by the end of the planning award?
NIAID is looking for a complete, well-justified trial plan that can be implemented efficiently and credibly under a future trial implementation mechanism. The description highlights deliverables such as the protocol, manual of operations, data management and quality assurance procedures, regulatory and ethics submission materials, and operational plans (for recruitment, retention, safety monitoring, and multi-site coordination when relevant).
Does the FOA support planning for multi-site trials?
Yes, when relevant. The supported planning activities described include setting up operational plans for multi-site coordination.
Does the FOA include planning for recruitment, retention, and safety monitoring?
Yes. The opportunity description specifically mentions preparing operational plans for recruitment, retention, and safety monitoring as part of the planning work.
What is the funding instrument type?
The funding instrument is a grant.
What is the award ceiling for this opportunity?
The listed award ceiling is $150,000.
What CFDA number is associated with this opportunity?
The opportunity corresponds to CFDA number 93.855.
What category is this opportunity listed under?
The award is categorized under Health.
When was this FOA created and what was the original closing date?
The opportunity was created on 2019-05-15 and had an original closing date of 2020-08-05.
Is this FOA still active?
The information provided indicates it was issued during 2019-2020 and notes that interested applicants should confirm whether the FOA is still active or whether it has been reissued in an updated form.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic and certain non-domestic organizations. Examples listed include various levels of government (state, county, city or township, special district), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, tribal governments and tribal organizations, 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.
Are federally recognized tribal governments eligible?
Yes. Federally recognized Native American tribal governments are listed as eligible applicants.
Are tribal organizations that are not federally recognized tribal governments eligible?
Yes. Tribal organizations that are not federally recognized tribal governments are explicitly listed as eligible.
Are higher education institutions eligible?
Yes. Both public/state-controlled and private institutions of higher education are listed as eligible.
Are nonprofit organizations eligible?
Yes. Nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status (when not an institution of higher education) are listed as eligible.
Are for-profit organizations eligible?
Yes. For-profit organizations other than small businesses are listed as eligible, and small businesses are also listed as eligible.
Are faith-based or community-based organizations eligible?
Yes. The FOA explicitly notes faith-based or community-based organizations among the additional eligible applicant categories.
Are foreign (non-U.S.) organizations eligible?
Yes. The FOA includes non-domestic (non-U.S.) entities (foreign organizations) among eligible applicant categories.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are included among the additional eligible applicant categories.
Does the FOA encourage certain types of institutions to apply (for example, minority-serving institutions)?
Yes. The FOA lists several additional eligible applicant categories including 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), and Tribally Controlled Colleges and Universities (TCCUs).
What is the main practical purpose of this planning grant?
The key practical takeaway described is that the R34 is meant to de-risk and professionalize the early stages of an investigator-initiated clinical trial by funding the intensive planning work needed before a trial can responsibly begin. The goal is a complete, implementation-ready package guided by explicit milestones, without conducting the trial during the R34 period.
What should applicants do to ensure their proposed trial aligns with NIAID priorities?
Applicants are encouraged to review NIAID's mission and priority research areas on the Institute website to ensure the proposed trial fits NIAID's research mission and is likely to be considered high priority.
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