Opportunity Information: Apply for PAR 08 057
Apply for PAR 08 057
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "NIDDK Multi Center Clinical Study Implementation Planning Grants (U34)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research.
- This funding opportunity was created on Dec 5, 2008 and posted on Dec 19, 2007.
- Applicants must submit their applications by Mar 18, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Special district governments City or township governments Public housing authorities/Indian housing authorities State governments Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification).
- Foreign institutions are eligible to apply. Eligible agencies of the Federal Government can apply. Faith based or community based organizations can apply.
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Opportunity Summary:
The NIDDK Multi Center Clinical Study Implementation Planning Grants (U34) opportunity (PAR 08-057) is a National Institutes of Health funding program designed to help research teams get a complex, investigator-initiated, multi-center clinical study fully prepared before launching the actual trial or clinical study. NIDDK uses a two-step pathway for these kinds of projects: first, investigators apply for a U34 planning grant to do the intensive planning work, and then, only after completing the required planning products, they can apply for a U01 cooperative agreement that funds the real-world conduct of the multi-center clinical study. In practice, the U34 functions as a structured on-ramp that strengthens the scientific and operational readiness of a study, reduces avoidable design flaws, and ensures that the eventual U01 application is based on a mature protocol rather than a high-level concept.
The core purpose of the U34 is to support implementation planning and allow early, rigorous peer review at a stage where major design decisions can still be improved without wasting the resources that come with launching a full study. The FOA emphasizes four main objectives: first, to enable early peer review of the scientific rationale and overall justification for the proposed multi-center clinical study; second, to allow detailed assessment of the proposed design and protocol (so reviewers can evaluate whether the methods actually answer the clinical question); third, to provide funding and time to develop a complete study protocol and all associated documents, including a manual of operations; and fourth, to support development of other essential elements needed to conduct the clinical study smoothly across multiple sites. The manual of operations is a central deliverable because it typically standardizes procedures across sites, defines roles and responsibilities, and lays out consistent approaches for recruitment, data collection, intervention delivery, participant safety, and quality assurance.
This opportunity uses the U34 grant mechanism, and the listing describes the funding instrument type as a cooperative agreement. Functionally, applicants should expect the U34 to be a planning-focused award rather than a mechanism intended to pay for enrolling participants at scale or running the full multi-site study. The key point is that completion of U34-required products is a prerequisite to submit the follow-on U01 application that would fund the actual conduct of the multi-center clinical study. In other words, the U34 is not the study itself; it is the funded planning phase that must be successfully completed to move forward to the implementation phase.
Funding levels, project size, and award duration are not fixed because the scope of planning needs can vary widely across different clinical areas and study designs. The announcement notes that award amounts and timelines will differ from application to application, and that awards depend on the availability of funds and the presence of a sufficient number of high-quality, meritorious applications. This is a typical federal caveat, but it also signals that applicants should build budgets that clearly match realistic planning activities and justify why each cost is necessary to deliver a final, implementable protocol package.
Eligibility is broad and includes many types of domestic organizations and governments, such as public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status), for-profit organizations (including small businesses), state and local governments (including county, city/township, special district governments, and independent school districts), public housing authorities/Indian housing authorities, and Native American tribal governments and other tribal organizations. The opportunity also states that foreign institutions are eligible, eligible federal agencies may apply, and faith-based or community-based organizations may apply. Cost sharing or matching is not required. The program is associated with NIH and NIDDK (CFDA 93.847, Diabetes, Digestive, and Kidney Diseases Extramural Research), and it is categorized under the broad activity area of food and nutrition/health in the source data.
Key administrative details from the source record include the posted date (December 19, 2007), the original closing date (March 18, 2010), the current closing date shown as March 18, 2010, and an archive date of April 18, 2010, indicating the opportunity is no longer active in its original form. The full announcement was hosted on the NIH grants guide site at the provided link, and the contact listed for access or linking issues is the NIH Office of Extramural Research webmaster (FBOWebmaster@OD.NIH.GOV).
Overall, this FOA is best understood as a structured planning grant for teams proposing a multi-center clinical study in NIDDK-relevant areas, where the main output is a complete, review-ready, operationally realistic study protocol package. The intent is to improve study quality and feasibility before NIH commits the larger investment required to run a multi-site clinical study under the subsequent U01 cooperative agreement.
FAQs: NIDDK Multi Center Clinical Study Implementation Planning Grants (U34) (PAR-08-057)
What is the NIDDK Multi Center Clinical Study Implementation Planning Grants (U34) opportunity?
It is an NIH/NIDDK funding opportunity that supports the planning and implementation-preparation work needed to get a complex, investigator-initiated, multi-center clinical study ready to launch. The U34 is designed to fund the intensive planning stage before applying for the follow-on award that supports actually conducting the multi-site study.
What is the main goal of the U34 planning grant?
The main goal is to ensure a proposed multi-center clinical study is scientifically, operationally, and procedurally ready before the full study begins. The U34 supports development of a complete, implementable study protocol package and other essential elements so the later full-study application is based on a mature plan rather than a high-level concept.
Is the U34 meant to fund the actual conduct of the multi-center clinical study?
No. The U34 is a planning-focused award. It is not intended to pay for enrolling participants at scale or running the full multi-site clinical study. The actual conduct of the study is intended to be supported under the subsequent U01 cooperative agreement.
How does the two-step pathway (U34 then U01) work in this program?
NIDDK uses a two-step pathway for these projects: (1) investigators apply for a U34 planning grant to complete required planning activities and products; (2) after completing those U34-required products, investigators can apply for a U01 cooperative agreement to fund the real-world conduct of the multi-center clinical study.
Is completion of the U34 required before applying for the U01?
Yes. Completion of the U34-required products is described as a prerequisite to submit the follow-on U01 application that would fund the actual conduct of the multi-center clinical study.
What are the four main objectives emphasized in the FOA?
The FOA highlights four objectives: (1) enable early peer review of the scientific rationale and justification for the proposed multi-center clinical study; (2) allow detailed assessment of the proposed design and protocol; (3) provide funding and time to develop a complete study protocol and associated documents (including a manual of operations); and (4) support development of other essential elements needed to conduct the clinical study smoothly across multiple sites.
Why does the FOA emphasize early peer review during the planning phase?
The U34 structure supports rigorous peer review at a stage when major design choices can still be improved. This helps reduce avoidable design flaws and strengthens readiness before NIH considers making the larger investment associated with running a full multi-center clinical study.
What kinds of deliverables are expected under the U34?
The U34 supports development of a complete study protocol and associated documents, including a manual of operations, along with other essential elements needed to run a multi-center clinical study consistently and smoothly across sites.
What is a Manual of Operations, and why is it considered a central deliverable?
The manual of operations is a key planning product because it typically standardizes procedures across sites, defines roles and responsibilities, and lays out consistent approaches for recruitment, data collection, intervention delivery, participant safety, and quality assurance.
What funding mechanism does this opportunity use?
This opportunity uses the U34 grant mechanism. The listing also describes the funding instrument type as a cooperative agreement.
What does it mean that the funding instrument type is a cooperative agreement?
Based on the information provided, the instrument is identified as a cooperative agreement. In practical terms for this listing, the key takeaway is that the U34 is positioned as a structured planning phase leading to a subsequent U01 for study conduct.
Are the award amounts and project timelines fixed?
No. The announcement notes that award amounts and timelines can vary from application to application because planning needs differ widely depending on the clinical area and study design.
What does the FOA say about the availability of awards?
Awards are dependent on the availability of funds and on receiving a sufficient number of high-quality, meritorious applications.
How should applicants think about building the U34 budget?
Because budgets and timelines can vary, applicants should align the budget with realistic planning activities and clearly justify why each cost is necessary to deliver a final, implementable protocol package.
Is cost sharing or matching required?
No. Cost sharing or matching is not required.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic organizations and governments, including public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (including small businesses); state and local governments (including county, city/township, special district governments, and independent school districts); public housing authorities/Indian housing authorities; and Native American tribal governments and other tribal organizations.
Are foreign institutions eligible?
Yes. The opportunity states that foreign institutions are eligible.
Can federal agencies apply?
Yes. The opportunity indicates that eligible federal agencies may apply.
Can faith-based or community-based organizations apply?
Yes. The opportunity states that faith-based or community-based organizations may apply.
Which NIH institute is associated with this funding opportunity?
The program is associated with NIH and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
What is the CFDA number associated with this program?
The associated CFDA number provided is 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).
What is the general activity area for this opportunity?
It is categorized under the broad activity area of food and nutrition/health in the source data.
What types of studies is this U34 intended to support?
It is intended for complex, investigator-initiated, multi-center clinical studies in NIDDK-relevant areas, where the main output is a complete, review-ready, operationally realistic protocol package.
Is this opportunity currently active?
No. The source record shows a posted date of December 19, 2007, a closing date of March 18, 2010, and an archive date of April 18, 2010, indicating the opportunity is no longer active in its original form.
Where was the full announcement hosted?
The full announcement was hosted on the NIH grants guide site (link referenced in the source information).
Who is listed as the contact for access or linking issues?
The contact listed for access or linking issues is the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.
What is the simplest way to describe the role of the U34 in this program?
The U34 is a structured on-ramp: it funds the planning work needed to strengthen scientific and operational readiness so that any later U01 application is grounded in a fully developed, standardized, multi-site-ready protocol.
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