Opportunity Information: Apply for PAR 16 272
Apply for PAR 16 272
- The HHS-NIH11 in the health sector is offering a public funding opportunity titled "NIAID Clinical Trial Planning Grant (R34)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855, 93.856,.
- This funding opportunity was created on May 18, 2016 and posted on May 18, 2016.
- Applicants must submit their applications by May 13, 2019. (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 (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
The NIAID Clinical Trial Planning Grant (R34), published by the National Institute of Allergy and Infectious Diseases (NIAID) under NIH/HHS, is a discretionary grant opportunity designed specifically to fund the upfront work needed to get an investigator-initiated clinical trial ready to launch. Rather than paying for the clinical trial itself, this FOA supports the complete planning and design phase, including development of the key documents and operational details required for implementation. The emphasis is on setting up a trial that is ready to move forward efficiently and credibly once planning milestones are met.
Projects proposed under this announcement are expected to be hypothesis-driven and milestone-defined. In practical terms, NIAID is looking for clinical trials grounded in a clear scientific question with a well-justified study design, and with concrete deliverables and checkpoints that demonstrate steady progress toward trial readiness. The clinical trial concept also needs to align with NIAID's research mission and be considered a high priority for the Institute. Applicants are directed to review NIAID planning priorities and high-priority research areas to ensure their proposed trial planning work fits within what the Institute is actively trying to advance.
This opportunity is identified as PAR-16-272 and falls within the NIH health activity category, associated with CFDA numbers 93.855 and 93.856. The funding instrument is a grant, and the program is structured for a broad range of applicant organizations. Eligible applicants include federal and non-federal governmental entities (such as state, county, city/township, special district governments, and independent school districts), public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education in those categories), for-profit organizations other than small businesses, small businesses, and certain Native American tribal governments and tribal organizations. Public housing authorities and Indian housing authorities are also listed among eligible entities, along with other categories as noted in the FOA's additional eligibility guidance.
From a budgeting standpoint, the posted award ceiling is $150,000. The posting does not specify the exact number of awards expected in the summary field provided, but the ceiling indicates the program is intended to cover planning activities rather than the full costs of running a clinical trial. Typical R34-supported activities generally involve finalizing the protocol and statistical analysis plan, developing study manuals and procedures, setting up data and safety monitoring plans, preparing regulatory and ethics submissions, building case report forms and data management systems, confirming site feasibility and operational capacity, and assembling the full documentation package needed to initiate enrollment once subsequent funding or approval is in place.
Key timeline details in the source listing include an original and current closing date of May 13, 2019, with the opportunity originally created and posted on May 18, 2016. Overall, the program is best understood as a planning bridge: it helps investigators turn a strong clinical trial idea into a fully specified, implementation-ready trial package that fits NIAID priorities and meets NIH expectations for rigorous design, feasibility, and readiness to execute.
Frequently Asked Questions (FAQs): NIAID Clinical Trial Planning Grant (R34) - PAR-16-272
What is the NIAID Clinical Trial Planning Grant (R34)?
The NIAID Clinical Trial Planning Grant (R34) is a discretionary grant opportunity from the National Institute of Allergy and Infectious Diseases (NIAID) under NIH/HHS. It is designed to fund the upfront planning and design work needed to prepare an investigator-initiated clinical trial for launch.
What is the purpose of this funding opportunity?
The purpose is to support the complete planning and design phase of a clinical trial, including producing the key documents and operational details required for implementation. The emphasis is on creating a trial that is ready to move forward efficiently and credibly once planning milestones are completed.
Does this grant pay for running the clinical trial?
No. This funding opportunity supports planning and design activities only. It does not pay for conducting the clinical trial itself.
What kinds of projects are expected under this FOA?
Projects are expected to be hypothesis-driven and milestone-defined. NIAID is looking for trials grounded in a clear scientific question, a well-justified study design, and concrete deliverables and checkpoints that demonstrate progress toward trial readiness.
What does NIAID mean by "milestone-defined"?
Based on the listing, this means the planning work should be organized around specific deliverables and checkpoints that show steady progress toward producing an implementation-ready clinical trial package.
Do proposed trials have to align with NIAID priorities?
Yes. The clinical trial concept needs to align with NIAID's research mission and be considered a high priority for the Institute. Applicants are directed to review NIAID planning priorities and high-priority research areas to confirm fit.
What is the FOA number for this opportunity?
This opportunity is identified as PAR-16-272.
Which agency is offering this grant?
The grant is offered by the National Institute of Allergy and Infectious Diseases (NIAID) under NIH/HHS.
What is the funding instrument type?
The funding instrument is a grant.
What CFDA numbers are associated with this opportunity?
The listing associates this opportunity with CFDA numbers 93.855 and 93.856.
What is the award ceiling?
The posted award ceiling is $150,000.
How many awards are expected?
The summary field provided in the source listing does not specify the exact number of awards expected.
What types of activities are typically supported with R34 planning funds?
The listing describes typical R34-supported planning activities as work such as finalizing the protocol and statistical analysis plan, developing study manuals and procedures, setting up data and safety monitoring plans, preparing regulatory and ethics submissions, building case report forms and data management systems, confirming site feasibility and operational capacity, and assembling the documentation package needed to initiate enrollment once later funding or approvals are in place.
What is meant by "investigator-initiated" in this context?
Based on the description, the opportunity supports clinical trials proposed by investigators (as opposed to trials that are primarily designed and initiated by the funding institute), with the R34 supporting the planning work needed to get those trials ready to launch.
Who is eligible to apply?
The opportunity is structured for a broad range of applicant organizations. Eligible applicants include federal and non-federal governmental entities (including state, county, city/township, special district governments, and independent school districts), public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education in those categories), for-profit organizations other than small businesses, small businesses, certain Native American tribal governments and tribal organizations, public housing authorities, and Indian housing authorities, along with other categories as noted in the FOA's additional eligibility guidance.
Are small businesses eligible?
Yes. Small businesses are listed among the eligible applicants.
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 nonprofit organizations eligible if they do not have 501(c)(3) status?
Yes. The listing includes nonprofit organizations with or without 501(c)(3) status, with the caveat that they are not institutions of higher education in those categories.
Are colleges and universities eligible?
Yes. Public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible applicants.
Are local or state government entities eligible?
Yes. State, county, and city/township governments are listed as eligible applicants, as well as special district governments and other governmental entities noted in the listing.
Are Native American tribal governments or organizations eligible?
Yes. Certain Native American tribal governments and tribal organizations are listed among eligible entities.
Are public housing authorities eligible?
Yes. Public housing authorities and Indian housing authorities are specifically listed among eligible applicants.
What is the closing date for this opportunity in the source listing?
The source listing shows an original and current closing date of May 13, 2019.
When was this opportunity originally created and posted?
The source listing indicates the opportunity was originally created and posted on May 18, 2016.
How should this grant be understood in the overall clinical trial process?
The program is best understood as a planning bridge. It helps investigators turn a strong clinical trial idea into a fully specified, implementation-ready trial package that fits NIAID priorities and meets NIH expectations for rigorous design, feasibility, and readiness to execute.
What is the main emphasis of NIAID for applications under this FOA?
The main emphasis is on supporting the planning and design work that results in a credible, well-documented, operationally feasible clinical trial plan that can move forward efficiently after meeting planning milestones.
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