Opportunity Information: Apply for PAR 15 068
Apply for PAR 15 068
- 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 Cooperative Agreements (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 11, 2014 and posted on Dec 11, 2014.
- Applicants must submit their applications by Sep 7, 2017. (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 $225,000.00 in funding.
- Eligible applicants include: County governments Special district governments For profit organizations other than small businesses Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) State governments City or township governments Public and State controlled institutions of higher education Small businesses Private institutions of higher education Public housing authorities/Indian housing authorities Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NIDDK Multi Center Clinical Study Implementation Planning Cooperative Agreements (U34) opportunity (Funding Opportunity Number PAR 15 068) is an NIH cooperative agreement mechanism meant to help investigators plan and finalize the key building blocks needed to launch a large, investigator-initiated, multi-center clinical study. NIDDK is specifically focused on studies that involve three or more clinical sites and that are hypothesis-driven, with the disease area clearly aligned to NIDDKs mission in diabetes, digestive diseases, and kidney diseases (CFDA 93.847). Rather than funding full study execution right away, this U34 supports a structured planning phase that strengthens the scientific rationale and operational readiness before a larger implementation award is pursued.
The U34 is positioned as the first part of a two-part process. Its main purpose is to allow early peer review of whether the proposed clinical study is compelling and well-justified, and to provide a formal mechanism to scrutinize and improve the study design and protocol before major resources are committed to participant enrollment and long-term study operations. In practical terms, applicants use the U34 period to lock down the protocol details, operational workflows, and the foundational documents that multi-site studies require to run consistently across locations.
A central deliverable under the U34 is the development of study documentation and infrastructure that make the subsequent clinical trial feasible and reproducible. This includes creating a Manual of Operations (often referred to as an MOP), which typically standardizes everything from eligibility screening and recruitment procedures to intervention delivery, safety monitoring, outcome assessments, training requirements, data handling, and quality control across all participating sites. Beyond the MOP, the U34 can support development of other essential elements for conduct of the clinical study, such as finalized case report forms, data management plans, site training and certification plans, draft informed consent templates, recruitment and retention strategies, monitoring approaches, and other protocol-driven tools that need to be harmonized across a network.
This funding opportunity is categorized as a discretionary grant using the cooperative agreement instrument, which generally implies more substantial programmatic involvement from the NIH compared with a standard research project grant. The activity category is listed under Food and Nutrition and Health, and it is administered by the National Institutes of Health through NIDDK. The announcement strongly encourages prospective applicants to consult with NIDDK scientific or research staff before submitting an application, which is often important for confirming mission relevance, fit to the mechanism, and expectations for milestones and planning-phase outputs.
From an applicant eligibility standpoint, the opportunity is broadly open to many U.S.-based organization types, including state, county, and local governments; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; small businesses; for-profit organizations other than small businesses; independent school districts; special district governments; public housing authorities/Indian housing authorities; and eligible tribal entities and organizations. The eligibility language also notes inclusion of various minority-serving institutions and community-based or faith-based organizations, among others. Foreign organizations and foreign institutions are not eligible to apply directly, and non-U.S. components of U.S. organizations are not eligible to apply; however, foreign components as defined by NIH policy are allowed, which can matter for studies that need certain specialized capabilities or populations outside the U.S. while still being led by an eligible domestic applicant.
Financially, the opportunity lists an award ceiling of $225,000 and indicates there is no cost sharing or matching requirement. The funding opportunity was posted and created on December 11, 2014, with an original and current closing date of September 7, 2017, and an archive date of October 8, 2017, meaning the specific announcement is no longer active for new submissions, but it remains a useful reference point for understanding how NIDDK structures planning support for multi-center clinical studies under the U34 mechanism.
Applicants looking for the full official announcement can reference the NIH guide link associated with PAR 15 068. For technical issues accessing the announcement, the contact provided is the NIH Office of Extramural Research webmaster (FBOWebmaster@OD.NIH.GOV).
FAQs: NIDDK Multi Center Clinical Study Implementation Planning Cooperative Agreements (U34) (PAR-15-068)
What is the NIDDK U34 (PAR-15-068) designed to support?
This opportunity supports a structured planning phase for a large, investigator-initiated, multi-center clinical study. It is meant to help investigators plan and finalize the key building blocks needed to launch the study, rather than funding full study execution immediately.
Is this award for running the clinical study or for planning it?
It is for planning. The U34 mechanism supports protocol and operational development so that a later, larger implementation award can be pursued with a stronger scientific rationale and higher operational readiness.
How does NIDDK position the U34 in the overall funding pathway?
The U34 is described as the first part of a two-part process. It allows early peer review of whether the proposed study is compelling and well-justified and provides a formal mechanism to scrutinize and improve the study design and protocol before major resources are committed.
What kind of clinical study does NIDDK expect under this U34?
NIDDK is focused on hypothesis-driven, investigator-initiated, multi-center clinical studies that involve three or more clinical sites and are clearly aligned with NIDDKs mission in diabetes, digestive diseases, and kidney diseases.
How many clinical sites are expected for studies under this opportunity?
The opportunity is specifically focused on studies that involve three or more clinical sites.
Which disease areas are considered aligned with this opportunity?
The disease area should be clearly aligned to NIDDKs mission in diabetes, digestive diseases, and kidney diseases.
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.847.
What is the main purpose of the planning phase funded by the U34?
The main purpose is to strengthen both the scientific rationale and operational readiness by finalizing the study design, protocol details, workflows, and foundational multi-site documentation before moving into participant enrollment and long-term operations under a later award.
What are typical deliverables expected during the U34 period?
Deliverables include study documentation and infrastructure needed to make the later clinical trial feasible and reproducible across sites. The announcement highlights development of a Manual of Operations (MOP) and other harmonized protocol-driven tools.
What is a Manual of Operations (MOP) and why is it important here?
A Manual of Operations (MOP) is a central planning deliverable that standardizes how the study will be run across all participating sites. It typically covers eligibility screening, recruitment procedures, intervention delivery, safety monitoring, outcome assessments, training requirements, data handling, and quality control so that the study is conducted consistently across locations.
Besides the MOP, what other planning materials can the U34 support?
The U34 can support development of essential elements such as finalized case report forms, data management plans, site training and certification plans, draft informed consent templates, recruitment and retention strategies, monitoring approaches, and other tools that must be harmonized across a multi-site network.
What does it mean that this is a cooperative agreement (U34) rather than a standard grant?
This opportunity uses the cooperative agreement instrument, which generally implies more substantial NIH programmatic involvement compared with a standard research project grant.
Which federal agency and NIH institute administer this opportunity?
The opportunity is administered by the National Institutes of Health (NIH) through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
What activity category is this opportunity listed under?
The activity category is listed under Food and Nutrition and Health.
Does NIDDK encourage contact before applying?
Yes. The announcement strongly encourages prospective applicants to consult with NIDDK scientific or research staff before submitting an application to help confirm mission relevance, fit to the mechanism, and expectations for milestones and planning-phase outputs.
Who is eligible to apply?
Eligibility is broadly open to many U.S.-based organization types, including state, county, and local governments; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; small businesses; for-profit organizations other than small businesses; independent school districts; special district governments; public housing authorities/Indian housing authorities; and eligible tribal entities and organizations. The eligibility language also notes inclusion of various minority-serving institutions and community-based or faith-based organizations, among others.
Are foreign organizations eligible to apply directly?
No. Foreign organizations and foreign institutions are not eligible to apply directly under this opportunity.
Are non-U.S. components of U.S. organizations eligible to apply?
No. Non-U.S. components of U.S. organizations are not eligible to apply.
Are any foreign activities allowed at all?
Yes. While foreign organizations cannot apply directly and non-U.S. components cannot apply, foreign components (as defined by NIH policy) are allowed. This can be relevant when a study needs specialized capabilities or populations outside the U.S. while still being led by an eligible domestic applicant.
What is the maximum award amount listed for this opportunity?
The opportunity lists an award ceiling of $225,000.
Is cost sharing or matching required?
No. The opportunity indicates there is no cost sharing or matching requirement.
When was this funding opportunity posted?
It was posted (and created) on December 11, 2014.
What were the closing date and archive date for PAR-15-068?
The original and current closing date listed is September 7, 2017, and the archive date is October 8, 2017.
Is this specific announcement still active for new submissions?
No. Based on the closing and archive dates provided, this specific announcement is no longer active for new submissions. It remains a useful reference for understanding how NIDDK structures planning support for multi-center clinical studies under the U34 mechanism.
Where can applicants find the official announcement?
Applicants can reference the NIH guide link associated with PAR-15-068 for the full official announcement.
Who should be contacted for technical issues accessing the announcement?
For technical issues accessing the announcement, the contact provided is the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.
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