Opportunity Information: Apply for PAR 06 384
Apply for PAR 06 384
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAID Clinical Trial Planning (R34) Grants" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855 Allergy, Immunology and Transplantation Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Mar 13, 2009 and posted on May 4, 2006.
- Applicants must submit their applications by Jan 7, 2010 Multiple Receipt Dates See Link to Full Announcement for details.. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education State governments Independent school districts Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Special district governments Native American tribal governments (Federally recognized) City or township governments Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
- Foreign institutions are eligible to apply. Eligible agencies of the Federal Government can apply.
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Opportunity Summary:
The NIAID Clinical Trial Planning (R34) Grants opportunity (Funding Opportunity Number PAR-06-384) is a discretionary NIH grant mechanism designed specifically to help investigators plan and design clinical trials in NIAID mission areas, including allergy, immunology and transplantation research (CFDA 93.855) and microbiology and infectious diseases research (CFDA 93.856). The purpose of the R34 is not to fund the conduct of the clinical trial itself, but to support the upfront work needed to responsibly prepare a strong, feasible clinical trial implementation proposal.
This R34 provides short-term planning support for up to one year. Budgets are capped based on the phase of the trial being planned: applicants may request up to $75,000 in direct costs to plan and design a Phase I clinical trial, and up to $150,000 in direct costs to plan and design a Phase II, III, or IV clinical trial. There is no cost sharing or matching requirement listed for this opportunity, which means applicants are not required to contribute additional non-federal funds as a condition of the award.
A notable requirement is that NIAID pre-approval is required before an R34 application can be submitted. In practice, this means potential applicants must contact NIAID and receive authorization to apply, typically to confirm programmatic fit, readiness, and that the proposed planning activities align with NIAID priorities and the intent of the mechanism. Once submitted, R34 applications are peer reviewed by NIAID initial review groups, indicating that scientific and technical merit are evaluated through NIH peer review processes rather than solely through internal administrative review.
The expected outcome of an R34 is very concrete. The main deliverable is either (1) a subsequent application for clinical trial implementation through a U01 cooperative agreement mechanism, or (2) a written document that summarizes the planning work completed and clearly explains why the team is not moving forward to a U01 implementation application. This structure emphasizes that the R34 is a go/no-go planning award: it is meant to reduce risk, strengthen study design, and ensure that only trials with solid justification, feasible operations, and appropriate protections advance to implementation funding.
Eligibility is broad and includes both domestic and foreign institutions. Eligible applicant organizations include for-profit and non-profit entities, public or private institutions such as universities, colleges, hospitals, and laboratories, as well as various levels of government (state, local, county, city/township, special district governments), tribal governments and tribal organizations, independent school districts, public housing authorities/Indian housing authorities, and eligible federal government institutions. Both 501(c)(3) nonprofits and nonprofits without 501(c)(3) status (other than institutions of higher education) are included as eligible applicant types in the listing, reflecting NIH's wide organizational eligibility when the scientific rationale and capability are strong.
The opportunity is open with respect to who may serve as the Project Director/Principal Investigator (PD/PI). Any individual with the skills, knowledge, and resources necessary to carry out the proposed planning activities may apply through their institution. NIH also explicitly encourages applications from individuals from underrepresented racial and ethnic groups and from individuals with disabilities, consistent with NIH-wide efforts to broaden participation in biomedical research leadership. Applicants are allowed to submit more than one application as long as each submission is scientifically distinct, meaning that multiple different planning projects can be proposed by the same applicant when they are clearly separate studies.
Administratively, the announcement was posted May 4, 2006, with multiple receipt dates and an original closing structure that culminated in the archived status (archive date February 7, 2010; current closing date listed as January 7, 2010 with multiple receipt dates referenced in the full announcement). The full program announcement is linked through NIH at http://grants.nih.gov/grants/guide/pa-files/PAR-06-384.html, and the general NIH Office of Extramural Research (OER) webmaster contacts are provided for access or linking issues.
FAQs: NIAID Clinical Trial Planning (R34) Grants (PAR-06-384)
What is the NIAID Clinical Trial Planning (R34) grant (PAR-06-384)?
The NIAID Clinical Trial Planning (R34) grant (Funding Opportunity Number PAR-06-384) is a discretionary NIH grant mechanism intended to support the planning and design of a clinical trial in areas aligned with the mission of the National Institute of Allergy and Infectious Diseases (NIAID).
What is the purpose of this R34 opportunity?
The R34 is meant to fund the upfront work needed to responsibly prepare a strong and feasible clinical trial implementation proposal. It supports planning and design activities rather than paying for the actual conduct of the clinical trial.
Does the R34 fund the conduct of the clinical trial?
No. The R34 described here is specifically for planning and design activities. It is not intended to fund the implementation or conduct of the clinical trial itself.
Which NIAID mission areas are included?
This opportunity covers clinical trial planning in NIAID mission areas, including allergy, immunology and transplantation research (CFDA 93.855) and microbiology and infectious diseases research (CFDA 93.856).
How long can R34 support last under this announcement?
This R34 provides short-term planning support for up to one year.
What are the budget limits for this R34?
Direct costs are capped based on the phase of the trial being planned. Applicants may request up to $75,000 in direct costs to plan and design a Phase I clinical trial, and up to $150,000 in direct costs to plan and design a Phase II, III, or IV clinical trial.
Are the budget caps based on the phase of the clinical trial being planned?
Yes. The allowable direct costs differ depending on whether the planning work is for a Phase I trial versus a Phase II, III, or IV trial.
Is cost sharing or matching required?
No cost sharing or matching requirement is listed for this opportunity. Applicants are not required to contribute non-federal funds as a condition of the award, based on the information provided.
Is NIAID pre-approval required before applying?
Yes. NIAID pre-approval is required before an R34 application can be submitted, meaning prospective applicants must contact NIAID and receive authorization to apply.
Why is pre-approval required?
Pre-approval is typically used to confirm programmatic fit, readiness, and that the proposed planning activities align with NIAID priorities and the intent of the R34 mechanism.
How are applications reviewed?
Applications are peer reviewed by NIAID initial review groups, indicating that scientific and technical merit are evaluated through NIH peer review processes rather than only internal administrative review.
What is the expected outcome or deliverable of an R34 award?
The primary expected outcome is either (1) a subsequent application for clinical trial implementation through a U01 cooperative agreement mechanism, or (2) a written document summarizing the planning work completed and clearly explaining why the team is not moving forward to a U01 implementation application.
Is the R34 considered a "go/no-go" planning award?
Yes. The structure described emphasizes that the R34 is intended to reduce risk, strengthen study design, and ensure that only trials with solid justification and feasible operations move forward to implementation funding.
What implementation mechanism is referenced as the next step after an R34?
The opportunity describes a subsequent clinical trial implementation application through a U01 cooperative agreement mechanism as the typical next step if the planning work supports moving forward.
Who is eligible to apply as an organization?
Eligibility is broad and includes domestic and foreign institutions. Eligible applicant organizations include for-profit and non-profit entities; public or private institutions such as universities, colleges, hospitals, and laboratories; and multiple levels of government (state, local, county, city/township, and special district governments). The listing also includes tribal governments and tribal organizations, independent school districts, public housing authorities/Indian housing authorities, and eligible federal government institutions.
Are both domestic and foreign institutions eligible?
Yes. The opportunity states that both domestic and foreign institutions are eligible.
Are for-profit organizations eligible to apply?
Yes. For-profit entities are included among eligible applicant organizations.
Are non-profit organizations eligible to apply?
Yes. Non-profit entities are eligible, including 501(c)(3) organizations and non-profits without 501(c)(3) status (other than institutions of higher education), as described in the eligibility listing.
Can universities, hospitals, and laboratories apply?
Yes. Public or private institutions such as universities, colleges, hospitals, and laboratories are explicitly included as eligible applicant types.
Are government entities eligible to apply?
Yes. Various government entities are listed as eligible, including state, local, county, city/township, and special district governments, along with eligible federal government institutions.
Are tribal governments and tribal organizations eligible to apply?
Yes. Tribal governments and tribal organizations are included among eligible applicant organizations.
Who can serve as the Project Director/Principal Investigator (PD/PI)?
Any individual with the skills, knowledge, and resources necessary to carry out the proposed planning activities may apply through their institution.
Does NIH encourage applications from underrepresented groups?
Yes. NIH explicitly encourages applications from individuals from underrepresented racial and ethnic groups and from individuals with disabilities.
Can an applicant submit more than one application?
Yes. Applicants may submit more than one application as long as each submission is scientifically distinct, meaning the proposals are clearly separate studies.
When was this funding opportunity announced?
The announcement was posted on May 4, 2006.
Is this opportunity still open?
Based on the information provided, the announcement is archived. An archive date of February 7, 2010 is listed, and a closing date of January 7, 2010 is referenced with multiple receipt dates in the full announcement.
Where can applicants find the full program announcement?
The full program announcement is available through NIH at http://grants.nih.gov/grants/guide/pa-files/PAR-06-384.html.
Who is listed for help with access or linking issues?
The general NIH Office of Extramural Research (OER) webmaster contacts are provided for access or linking issues, as noted in the opportunity information.
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