Opportunity Information: Apply for PAR 15 067
Apply for PAR 15 067
- 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 Dec 11, 2014 and posted on Dec 11, 2014.
- Applicants must submit their applications by May 7, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Special district governments County governments Independent school districts Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Native American tribal governments (Federally recognized) State governments Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Public and State controlled institutions of higher education For profit organizations other than small businesses Private institutions of higher education Public housing authorities/Indian housing authorities 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 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 Cooperative Agreement (U01) (Funding Opportunity Number PAR-15-067) is an NIH funding opportunity designed to support investigator-initiated, multi-center clinical studies that address diseases and conditions within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The emphasis is on hypothesis-driven clinical research conducted across more than one study site, which typically allows investigators to recruit broader and more diverse participant populations, improve generalizability, and accelerate enrollment compared with single-site work. Because this is a cooperative agreement (U01) rather than a standard research project grant, awardees should expect substantial scientific and/or programmatic involvement from NIH/NIDDK staff during the conduct of the study, consistent with how cooperative agreements operate.
A key feature of this FOA is that it is intended strictly for the conduct of the multi-center clinical study itself, not for early planning. The announcement makes it clear that planning activities must be completed before submitting a U01 application under this opportunity, and that planning work is not allowed as part of the U01 scope. If a team needs time and support to finalize study logistics, coordination, and readiness steps before launching, the FOA points applicants instead to an implementation planning cooperative agreement mechanism, the U34 (referenced as PAR-15-068). In practical terms, this means applicants are expected to come in with a well-developed protocol, clear site readiness, and the operational details worked out in advance, rather than proposing to use the first award period to build the foundation.
The program strongly encourages prospective applicants to consult with NIDDK scientific/research staff before submitting an application, whether applying directly to the U01 or first pursuing the U34 planning mechanism. That consultation is typically important for confirming fit with NIDDK priorities, ensuring the proposed design and endpoints align with institute expectations for clinical studies, and clarifying the cooperative agreement features and any institute-specific considerations that could affect feasibility, timelines, or review.
Administratively, this was a discretionary funding opportunity using the cooperative agreement funding instrument, categorized under Food and Nutrition and Health, with CFDA number 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research). It did not require cost sharing or matching. The FOA was posted and created on December 11, 2014, and the final listed closing date was May 7, 2018, with an archive date of June 7, 2018, indicating it is no longer open for new submissions under that specific announcement.
Eligibility was broad and included many types of domestic U.S. organizations and governmental entities, such as state, county, city/township, and special district governments; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with and without 501(c)(3) status; small businesses; and for-profit organizations other than small businesses. It also included eligible tribal governments and tribal organizations, as well as public housing authorities/Indian housing authorities. The eligibility section further highlighted a range of institution types and community-focused entities that could apply, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American and Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations and U.S. territories or possessions. Non-U.S. entities (foreign organizations and foreign institutions) were not eligible to apply directly, and non-U.S. components of U.S. organizations were also not eligible to apply; however, foreign components, as defined by NIH policy, were allowed, which typically means a U.S. applicant could include certain international elements when appropriately justified and structured under NIH rules.
For reference and full details, the original announcement was hosted on the NIH Grants Guide site (link provided in the source). For technical access issues with the online posting, the contact listed was the NIH Office of Extramural Research (OER) webmaster (FBOWebmaster@OD.NIH.GOV).
Frequently Asked Questions (FAQs)
What is this funding opportunity?
This opportunity is the NIDDK Multi Center Clinical Study Cooperative Agreement (U01), Funding Opportunity Number (FON) PAR-15-067. It is an NIH/NIDDK mechanism intended to support investigator-initiated, multi-center clinical studies that address diseases and conditions within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
What kind of research does PAR-15-067 support?
It supports hypothesis-driven clinical research conducted across more than one study site (multi-center clinical studies). The goal is to enable broader and more diverse participant recruitment, improve generalizability of findings, and accelerate enrollment compared with single-site studies.
What does "multi-center" mean in this announcement?
In this context, "multi-center" means the clinical study is conducted across more than one study site.
What diseases or conditions are in scope?
The study must address diseases and conditions within NIDDK's mission areas: diabetes, digestive diseases, and kidney diseases (as reflected in the CFDA listing for Diabetes, Digestive, and Kidney Diseases Extramural Research).
What is the funding instrument used for this opportunity?
This FOA uses the cooperative agreement funding instrument, specifically a U01. Cooperative agreements involve substantial scientific and/or programmatic involvement from NIH/NIDDK staff during the conduct of the study, consistent with how cooperative agreements operate.
How is a U01 cooperative agreement different from a standard research project grant?
Under a U01, awardees should expect substantial scientific and/or programmatic involvement from NIH/NIDDK staff during the conduct of the study. This is a key distinction from standard research project grants where NIH involvement is typically less direct.
Is this FOA meant for planning a study or running the study?
This FOA is intended strictly for conducting the multi-center clinical study itself. It is not intended for early planning activities.
Are planning activities allowed within the U01 scope under PAR-15-067?
No. The announcement states that planning activities must be completed before submitting a U01 application under this opportunity, and that planning work is not allowed as part of the U01 scope.
What if our team still needs time and support to finalize logistics and readiness before launching?
If additional time and support are needed to finalize study logistics, coordination, and readiness steps before launching, applicants are pointed to an implementation planning cooperative agreement mechanism, the U34 (referenced as PAR-15-068).
What level of readiness is expected at the time of U01 application?
Applicants are expected to submit with a well-developed protocol, clear site readiness, and operational details worked out in advance, rather than proposing to use the first award period to build the study foundation.
Is it recommended to contact NIDDK before applying?
Yes. The program strongly encourages prospective applicants to consult with NIDDK scientific/research staff before submitting an application, whether applying directly to the U01 or first pursuing the U34 planning mechanism.
Why is consultation with NIDDK staff encouraged?
Consultation is typically important for confirming fit with NIDDK priorities, ensuring the proposed design and endpoints align with institute expectations for clinical studies, and clarifying cooperative agreement features and any institute-specific considerations that could affect feasibility, timelines, or review.
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.847, identified as Diabetes, Digestive, and Kidney Diseases Extramural Research.
What category was this opportunity listed under?
It was categorized under Food and Nutrition and Health.
Was cost sharing or matching required?
No. The announcement indicated that it did not require cost sharing or matching.
Is PAR-15-067 still open for new submissions?
No. The final listed closing date was May 7, 2018, and the archive date was June 7, 2018, indicating it is no longer open for new submissions under that specific announcement.
When was this FOA created and posted?
It was posted and created on December 11, 2014.
Who was eligible to apply (in general terms)?
Eligibility was broad and included many types of domestic U.S. organizations and governmental entities, including various levels of government, higher education institutions (public and private), nonprofits (with and without 501(c)(3) status), small businesses, and for-profit organizations other than small businesses.
Which government entities were included as eligible applicants?
Eligible governmental entities included state governments, county governments, city/township governments, special district governments, and eligible tribal governments.
Were tribal organizations and housing authorities eligible?
Yes. Eligibility included tribal organizations and public housing authorities/Indian housing authorities.
Were specific institution types (like MSIs) called out as eligible?
Yes. The eligibility section highlighted Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American and Native American Pacific Islander Serving Institutions (AANAPISIs).
Were faith-based or community-based organizations mentioned as eligible?
Yes. Faith-based or community-based organizations were included among the highlighted eligible entities.
Were U.S. territories or possessions included in eligibility?
Yes. U.S. territories or possessions were included in the eligibility highlights.
Are non-U.S. (foreign) organizations eligible to apply directly?
No. Non-U.S. entities (foreign organizations and foreign institutions) were not eligible to apply directly.
Are non-U.S. components of U.S. organizations eligible?
No. Non-U.S. components of U.S. organizations were also not eligible to apply.
Are any international elements allowed at all?
Yes. Foreign components, as defined by NIH policy, were allowed. This generally means a U.S. applicant could include certain international elements when appropriately justified and structured under NIH rules.
Where could applicants find the original announcement?
The original announcement was hosted on the NIH Grants Guide site (with the link provided in the source material).
Who was listed as a contact for technical access issues with the online posting?
The contact listed for technical access issues was the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 15 067) also looked into and applied for these:
| Funding Opportunity |
|---|
| NIDDK Multi Center Clinical Study Implementation Planning Cooperative Agreements (U34) Apply for PAR 15 068 Funding Number: PAR 15 068 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $225,000 |
| Limited Competition for the Continuation of the Diabetes Prevention Program Outcomes Study (DPPOS) Clinical Centers (Collaborative U01) Apply for RFA DK 15 503 Funding Number: RFA DK 15 503 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Limited Competition for the Continuation of the Diabetes Prevention Program Outcomes Study (DPPOS) Biostatistics Research Center (Collaborative U01) Apply for RFA DK 15 505 Funding Number: RFA DK 15 505 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Agriculture and Food Research Initiative Food Safety Challenge Area Apply for USDA NIFA AFRI 004916 Funding Number: USDA NIFA AFRI 004916 Agency: National Institute of Food and Agriculture Category: Food and Nutrition Health Funding Amount: Case Dependent |
| NIDDK Research Education Program Grants for Courses for Skills Development (R25) Apply for PAR 15 139 Funding Number: PAR 15 139 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $100,000 |
| NIDDK Research Education Program Grants for Summer Research Experiences (R25) Apply for PAR 15 140 Funding Number: PAR 15 140 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $100,000 |
| NIDDK Research Education Program Grants for Curriculum Development (R25) Apply for PAR 15 138 Funding Number: PAR 15 138 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $100,000 |
| Limited Competition Continuation of the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study (U01) Apply for RFA DK 15 504 Funding Number: RFA DK 15 504 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care (R18) Apply for PAR 15 157 Funding Number: PAR 15 157 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Planning Grants for Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care (R34) Apply for PAR 15 158 Funding Number: PAR 15 158 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $150,000 |
| Limited Competition for the Continuation of Look AHEAD (Action for Health in Diabetes) Clinical Centers (Collaborative U01) Apply for RFA DK 15 501 Funding Number: RFA DK 15 501 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Limited Competition for the Continuation of Look AHEAD (Action for Health in Diabetes) Biostatistics Research Center (Collaborative U01) Apply for RFA DK 15 502 Funding Number: RFA DK 15 502 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Pilot and Feasibility Clinical Research Grants in Kidney Diseases (R21) Apply for PAR 15 161 Funding Number: PAR 15 161 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $200,000 |
| Pilot and Feasibility Clinical Research Grants in Urologic Disorders (R21) Apply for PAR 15 162 Funding Number: PAR 15 162 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $200,000 |
| New Directions in Hematology Research (SHINE II) (R01) Apply for PAS 15 168 Funding Number: PAS 15 168 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $200,000 |
| Secondary Analyses in Obesity, Diabetes and Digestive and Kidney Diseases (R21) Apply for PA 15 169 Funding Number: PA 15 169 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $200,000 |
| Pilot and Feasibility Clinical Trials in Diabetes, and Endocrine and Metabolic Diseases (R21) Apply for PA 15 176 Funding Number: PA 15 176 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $200,000 |
| Interdisciplinary Training in Bioinformatics and Diabetes, Obesity and Metabolic Disease (T32) Apply for PAR 15 182 Funding Number: PAR 15 182 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Career Development Programs in Diabetes Research for Pediatric Endocrinologists (K12) Apply for RFA DK 15 006 Funding Number: RFA DK 15 006 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Translational Research to Improve Outcomes in Kidney Diseases (R18) Apply for RFA DK 15 009 Funding Number: RFA DK 15 009 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $225,000 |
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