Opportunity Information: Apply for PAR 11 157
Apply for PAR 11 157
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "NIDDK Multi Center Clinical Study Cooperative Agreement (U01)" 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 Mar 16, 2011 and posted on Mar 16, 2011.
- Applicants must submit their applications by Sep 7, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Special district governments Public housing authorities/Indian housing authorities For profit organizations other than small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses State governments Independent school districts Public and State controlled institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) County governments City or township governments 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.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions 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 Foreign (non U.S.) components of U.S. Organizations are allowed.
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Opportunity Summary:
The NIDDK Multi-Center Clinical Study Cooperative Agreement (U01) funding opportunity (PAR 11-157) is a National Institutes of Health discretionary grant mechanism designed to support investigator-initiated, multi-center clinical studies in areas aligned with the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The focus is on clinical research that requires coordination across multiple clinical sites, where a cooperative agreement structure is appropriate because NIH staff are expected to have substantial programmatic involvement during the conduct of the study. The activity category is listed under Food and Nutrition Health, and the associated CFDA number is 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research). There is no cost sharing or matching requirement.
A central feature of this opportunity is that NIDDK uses a two-step process for these types of complex, multi-site trials and clinical studies. Applicants are generally not expected to jump straight into a full U01 application. Instead, the institute requires investigators to first complete an implementation planning phase supported through an implementation planning grant (U34; referenced as PAR 10-197). Under this policy, NIDDK will only accept and peer review U01 applications for investigator-initiated, multi-center clinical studies from investigators who already hold the required U34 award, unless NIDDK has explicitly granted an exemption from this prerequisite. In practical terms, that means the U34 functions as a gateway: it is used to develop and finalize the essential building blocks needed for a credible, feasible, and well-governed multi-center clinical study before the larger, more resource-intensive U01 is submitted. The funding announcement makes clear that completion of the required U34 products is not optional; it is a prerequisite to submitting the U01 application under this FOA (again, except where an exemption is approved by NIDDK).
Because the U01 is a cooperative agreement, it typically implies a more collaborative relationship with the NIH compared with a standard research project grant. While the specific roles and expectations are laid out in the full announcement, the general implication is that NIDDK staff may participate in study oversight, milestones, coordination, and other aspects of implementation that help ensure the multi-center study is carried out effectively. This structure is commonly used when studies are operationally complex, involve multiple enrolling sites, require harmonized protocols and data systems, and benefit from consistent federal involvement to support study integrity and performance across centers.
Eligibility for this opportunity is broad and includes many types of domestic and non-domestic organizations. Eligible applicants listed include state governments, county and city/township governments, special district governments, 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 (other than institutions of higher education), small businesses, and for-profit organizations other than small businesses. It also includes public housing authorities and Indian housing authorities. In addition, the FOA explicitly notes additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-Serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, U.S. territories or possessions, and tribal governments and tribal organizations (including those other than federally recognized). Foreign (non-U.S.) entities are allowed, and foreign components of U.S. organizations may participate, reflecting the fact that some multi-center clinical research questions and recruitment needs can extend beyond U.S. borders.
From an administrative standpoint, the announcement was posted and created on March 16, 2011, with an original and final closing date of September 7, 2014, and an archive date of October 8, 2014. The official announcement was hosted through the NIH grants system, with an additional information link pointing to the NIH Guide for Grants and Contracts page for PAR 11-157. For technical access issues, the contact provided is the NIH Office of Extramural Research (OER) webmaster.
In short, PAR 11-157 supports investigator-driven, multi-center clinical studies through the U01 cooperative agreement mechanism, but it is intentionally structured so that applicants first complete a dedicated U34 planning award to produce the finalized protocol and other required preparatory materials. Only after that planning work is completed (or an exemption is granted) will NIDDK accept, peer review, and consider a full U01 application for funding.
FAQs: NIDDK Multi-Center Clinical Study Cooperative Agreement (U01) - PAR 11-157
What is PAR 11-157?
PAR 11-157 is a National Institutes of Health (NIH) funding opportunity from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to support investigator-initiated, multi-center clinical studies using the U01 cooperative agreement mechanism.
What type of grant mechanism is used under this opportunity?
This opportunity uses the U01 mechanism, which is a cooperative agreement. It is described as an NIH discretionary grant mechanism for multi-center clinical studies where NIH staff are expected to have substantial programmatic involvement during the conduct of the study.
What kinds of research does this opportunity support?
It supports investigator-initiated, multi-center clinical studies that align with the mission of NIDDK. The opportunity is listed under the activity category Food and Nutrition Health.
Why is this a "multi-center" clinical study opportunity?
The focus is on clinical research that requires coordination across multiple clinical sites. This mechanism is intended for studies that are operationally complex, involve multiple enrolling sites, and require harmonized protocols and data systems.
What does it mean that this U01 is a cooperative agreement?
A cooperative agreement typically implies a more collaborative relationship with NIH than a standard research project grant. Under this structure, NIDDK staff may participate in study oversight, milestones, coordination, and other aspects of implementation to help ensure the multi-center study is conducted effectively.
Is there a required planning step before submitting a U01 application?
Yes. NIDDK uses a two-step process for these complex, multi-site clinical studies. Investigators are generally expected to complete an implementation planning phase supported through a U34 planning award (referenced as PAR 10-197) before submitting a full U01 application.
What is the U34 and how does it relate to the U01?
The U34 is an implementation planning grant used to develop and finalize key planning elements needed for a feasible and well-governed multi-center clinical study. In this process, the U34 functions as a gateway to the U01 by supporting the planning work required before NIDDK will accept a U01 application.
Will NIDDK accept a U01 application if the investigator does not already have the required U34?
Generally, no. NIDDK will only accept and peer review U01 applications for investigator-initiated, multi-center clinical studies from investigators who already hold the required U34 award, unless NIDDK has explicitly granted an exemption from this prerequisite.
Are the U34 planning products optional?
No. The funding announcement states that completion of the required U34 products is a prerequisite to submitting the U01 application under this FOA, except where an exemption is approved by NIDDK.
What is the purpose of the two-step (U34 then U01) process?
The two-step process is designed to ensure that essential building blocks for a credible, feasible, and well-governed multi-center clinical study are finalized before the larger, more resource-intensive U01 application is submitted.
Which institute at NIH is associated with this opportunity?
This opportunity is associated with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
What is the CFDA number associated with this funding opportunity?
The associated CFDA number is 93.847, titled Diabetes, Digestive, and Kidney Diseases Extramural Research.
Is cost sharing or matching required?
No. The information provided states there is no cost sharing or matching requirement.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic and non-domestic organizations, including various government entities, higher education institutions, nonprofit and for-profit organizations, small businesses, and additional designated organization types explicitly listed in the announcement.
Are state and local government entities eligible to apply?
Yes. Eligible applicants include state governments, county governments, city or township governments, special district governments, and independent school districts.
Are colleges and universities eligible?
Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education.
Are nonprofit organizations eligible?
Yes. Nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education) are included as eligible applicants.
Are businesses eligible to apply?
Yes. Eligible applicants include small businesses and for-profit organizations other than small businesses.
Are public housing authorities eligible?
Yes. Public housing authorities and Indian housing authorities are listed as eligible applicants.
Are minority-serving institutions specifically mentioned as eligible?
Yes. The announcement explicitly notes eligibility for Alaska Native and Native Hawaiian Serving Institutions, Hispanic-Serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly noted as additional eligible applicant types.
Are tribal governments and tribal organizations eligible?
Yes. Tribal governments and tribal organizations are listed as eligible, including those other than federally recognized.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are explicitly included among eligible applicant types.
Are federal agencies eligible to apply?
Yes. The FOA notes eligible federal agencies as an additional eligible applicant type.
Are foreign (non-U.S.) organizations eligible?
Yes. Foreign (non-U.S.) entities are allowed, and foreign components of U.S. organizations may participate.
Why might foreign entities or foreign components be relevant for this opportunity?
The opportunity reflects that some multi-center clinical research questions and recruitment needs can extend beyond U.S. borders.
When was this funding opportunity created and posted?
The announcement was created and posted on March 16, 2011.
What were the application closing dates for PAR 11-157?
The original and final closing date listed is September 7, 2014.
When was this funding opportunity archived?
The archive date listed is October 8, 2014.
Where was the official announcement hosted?
The official announcement was hosted through the NIH grants system, with an additional information link pointing to the NIH Guide for Grants and Contracts page for PAR 11-157.
Who should be contacted for technical access issues related to the announcement?
For technical access issues, the contact provided is the NIH Office of Extramural Research (OER) webmaster.
What is the main takeaway about applying to this opportunity?
The key point is that PAR 11-157 supports investigator-driven, multi-center clinical studies through a U01 cooperative agreement, but applicants are expected to complete a U34 implementation planning award first (unless NIDDK grants an exemption) before NIDDK will accept and peer review a full U01 application.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 11 157) also looked into and applied for these:
| Funding Opportunity |
|---|
| Diabetes Research Centers (P30) Apply for RFA DK 11 002 Funding Number: RFA DK 11 002 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Cystic Fibrosis Research and Translation Core Centers (P30) Apply for RFA DK 11 004 Funding Number: RFA DK 11 004 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $750,000 |
| Empowering New Generations to Improve Nutrition and Economic opportunities (ENGINE) An Integrated Nutrition Program Apply for RFA 663 11 000012 Funding Number: RFA 663 11 000012 Agency: Ethiopia USAID Addis Ababa Category: Food and Nutrition Health Funding Amount: $50,891,422 |
| NIDDK Short Term Education Program for Underrepresented Persons (STEP UP) (R25) Apply for RFA DK 11 011 Funding Number: RFA DK 11 011 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Collaborative Interdisciplinary Team Science in NIDDK Research Areas (R24) Apply for PAR 11 221 Funding Number: PAR 11 221 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
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