Opportunity Information: Apply for PAR 08 058
Apply for PAR 08 058
- 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 4, 2008 and posted on Dec 4, 2008.
- Applicants must submit their applications by May 7, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: 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 Native American tribal governments (Federally recognized) Private institutions of higher education Small businesses Public and State controlled institutions of higher education For profit organizations other than small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal organizations (other than Federally recognized tribal governments) State governments.
- 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) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The NIDDK Multi Center Clinical Study Cooperative Agreement (U01), Funding Opportunity Number PAR-08-058, was a National Institutes of Health discretionary funding announcement designed to support investigator-initiated, multi-center clinical studies in areas relevant to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). In practical terms, it targeted large clinical research efforts that require participation from multiple clinical sites, coordinated under a single overarching protocol, and it used a cooperative agreement structure (U01). That cooperative agreement model typically implies a more active programmatic role for the funding institute compared with a standard research grant, reflecting the complexity and coordination demands of multi-center clinical work.
A central feature of this opportunity was its required two-step pathway. NIDDK set up a process where investigators first complete an implementation planning phase supported by a separate grant mechanism, the NIDDK Multi Center Clinical Study Implementation Planning (U34). Starting with the June 5, 2008 receipt date, NIDDK stated it would accept, peer review, and consider U01 applications for investigator-initiated multi-center clinical studies only from teams that had already been awarded the related U34 planning grant, unless NIDDK explicitly granted an exemption. The intent of this structure was to ensure that major operational and scientific elements of a multi-center clinical study were fully developed, vetted, and packaged into required planning products before investigators moved into the full-scale U01 stage. In other words, completion of the U34 deliverables was not optional; it was a prerequisite for submitting the U01 application under this announcement.
Because the program focused on investigator-initiated studies rather than a single predefined study topic, the announcement anticipated wide variation in what applicants might propose. As a result, NIDDK emphasized that award sizes and project durations would vary from application to application, depending on the nature and scope of the proposed clinical research. The total dollars awarded and the number of awards were not fixed in advance; they would depend on factors such as the number of applications received, their scientific merit and feasibility, their proposed timelines, and the budget levels requested. The funding activity category was listed under health, with a connection to food and nutrition, and the associated CFDA number was 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research). There was no cost sharing or matching requirement.
Eligibility was broad and included many common research-performing organizations across the nonprofit, academic, government, and private sectors. Eligible applicants included 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. The announcement also included various governmental and community-based entities and special categories such as federally recognized Native American tribal governments, other Native American tribal organizations, U.S. territories or possessions, regional organizations, and a range of designated institution types (for example, Historically Black Colleges and Universities, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, and Alaska Native and Native Hawaiian-serving institutions). Faith-based and community-based organizations and eligible federal agencies were also listed as eligible in the additional eligibility information.
Key administrative dates show that the opportunity was posted and created on December 4, 2008, with an original and current closing date of May 7, 2011, and an archive date of June 7, 2011. The full announcement was hosted on the NIH grants website under the listed link. For access or technical issues, the contact provided was the NIH Office of Extramural Research (OER) webmaster email.
Frequently Asked Questions (FAQs)
What is this funding opportunity?
This opportunity is the NIDDK Multi Center Clinical Study Cooperative Agreement (U01) under Funding Opportunity Number PAR-08-058. It was a National Institutes of Health (NIH) discretionary funding announcement intended to support investigator-initiated, multi-center clinical studies in research areas relevant to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Which agency and institute offered this opportunity?
The opportunity was offered through the National Institutes of Health (NIH), specifically through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
What does "multi-center clinical study" mean in the context of this announcement?
In this announcement, a multi-center clinical study refers to a large clinical research effort that requires participation from multiple clinical sites. These sites operate under a single overarching protocol and are coordinated as one study rather than as separate, unrelated projects.
Is this opportunity for investigator-initiated studies or a pre-defined topic?
It was designed for investigator-initiated multi-center clinical studies rather than a single pre-defined study topic. Because of that, the announcement anticipated substantial variation in what applicants might propose.
What does the U01 cooperative agreement structure imply?
The U01 is a cooperative agreement mechanism. In practical terms, this model typically implies a more active programmatic role for the funding institute than a standard research grant, reflecting the complexity and coordination demands common in multi-center clinical studies.
Was there a required planning step before applying for the U01?
Yes. A central feature of this opportunity was a required two-step pathway. Investigators were expected to complete an implementation planning phase supported by a separate grant mechanism: the NIDDK Multi Center Clinical Study Implementation Planning (U34).
What is the U34, and how does it relate to the U01?
The U34 is an implementation planning grant mechanism intended to support planning activities for a multi-center clinical study. Under this announcement, the U34 was used to develop and package required planning products and key operational and scientific elements before moving to the full-scale U01 application stage.
Was having a U34 award required to submit a U01 application?
Yes. Starting with the June 5, 2008 receipt date, NIDDK stated it would accept, peer review, and consider U01 applications for investigator-initiated multi-center clinical studies only from teams that had already been awarded the related U34 planning grant, unless NIDDK explicitly granted an exemption.
Could applicants ever submit a U01 without first receiving a U34?
Only if NIDDK explicitly granted an exemption. Otherwise, the announcement described the U34 award as a prerequisite for submitting the U01 application.
Why did NIDDK require the U34 planning phase?
The intent was to ensure that major operational and scientific elements of a multi-center clinical study were fully developed, vetted, and packaged into required planning products before investigators moved into the full-scale U01 stage.
Were U34 deliverables optional?
No. The announcement described completion of U34 deliverables as not optional and as a prerequisite for submitting the U01 application under this announcement.
How much funding was available per award?
Award sizes were not fixed. NIDDK emphasized that award sizes would vary from application to application based on the nature and scope of the proposed clinical research.
How long could projects last under this program?
Project durations were not fixed in advance. NIDDK indicated that project durations would vary depending on the proposed study and its scope.
How many awards would be made under this opportunity?
The number of awards was not predetermined. The announcement stated that total dollars awarded and the number of awards would depend on factors including the number of applications received, scientific merit and feasibility, proposed timelines, and requested budget levels.
What factors would influence the final funding decisions?
Based on the announcement, factors included the number of applications received, their scientific merit and feasibility, their proposed timelines, and the budget levels requested.
Was cost sharing or matching required?
No. The announcement stated there was no cost sharing or matching requirement.
What was the funding activity category?
The funding activity category was listed under health, with a connection to food and nutrition.
What CFDA number was associated with this opportunity?
The associated CFDA number was 93.847, titled Diabetes, Digestive, and Kidney Diseases Extramural Research.
Who was eligible to apply?
Eligibility was broad and included many research-performing organizations across nonprofit, academic, government, and private sectors. Eligible applicants included 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.
Were tribal governments and tribal organizations eligible?
Yes. The eligible applicant list included federally recognized Native American tribal governments and other Native American tribal organizations.
Were U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions were included in the eligibility list described in the announcement.
Were special institution types (such as HBCUs or Hispanic-serving institutions) eligible?
Yes. The eligibility information explicitly included designated institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities, and Alaska Native and Native Hawaiian-serving institutions.
Were faith-based and community-based organizations eligible?
Yes. Faith-based and community-based organizations were listed as eligible in the additional eligibility information.
Were federal agencies eligible to apply?
Yes. Eligible federal agencies were listed as eligible in the additional eligibility information.
What were the key posting and closing dates for this opportunity?
The opportunity was posted and created on December 4, 2008. The original and current closing date was May 7, 2011. The archive date was June 7, 2011.
Where was the full announcement hosted?
The full announcement was hosted on the NIH grants website under the listed link in the opportunity information.
Who should be contacted for access or technical issues related to the announcement?
For access or technical issues, the contact provided was the NIH Office of Extramural Research (OER) webmaster email.
What makes this opportunity different from a single-site clinical study award?
Based on the description provided, this opportunity specifically targeted large clinical research efforts that require multiple clinical sites operating under a single protocol, along with a cooperative agreement structure that typically reflects greater institute involvement due to the coordination needs of multi-center work.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 08 058) also looked into and applied for these:
| Funding Opportunity |
|---|
| Secondary Analyses in Obesity, Diabetes, Digestive and Kidney Diseases (R21) Apply for PA 06 151 Funding Number: PA 06 151 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $200,000 |
| Small Grant Program for NIDDK K08/K23 Recipients (R03) Apply for PAR 06 172 Funding Number: PAR 06 172 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $50,000 |
| Pilot And Feasibility Clinical Research Studies In Digestive Diseases And Nutrition Apply for PA 06 301 Funding Number: PA 06 301 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $200,000 |
| NIDDK Education Program Grants (R25) Apply for PAR 06 554 Funding Number: PAR 06 554 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $100,000 |
| Research Grants for Studies of Hepatitis C in the Setting of Renal Disease (R01) Apply for PA 07 015 Funding Number: PA 07 015 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Proteomics Diabetes, Obesity, And Endocrine, Digestive, Kidney, Urologic, And Hematologic Diseases (R01) Apply for PA 07 016 Funding Number: PA 07 016 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Ancillary Studies to Major Ongoing NIDDK and NHLBI Clinical Research Studies (R01) Apply for PAR 07 024 Funding Number: PAR 07 024 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Non Invasive Methods for Diagnosis and Progression of Diabetes, Kidney, Urological, Hematological and Digestive Diseases (R01) Apply for PA 07 025 Funding Number: PA 07 025 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Health Disparities in NIDDK Diseases (R01) Apply for PA 07 027 Funding Number: PA 07 027 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| NIDDK Multi Center Clinical Study Implementation Planning Grants (U34) Apply for PAR 08 057 Funding Number: PAR 08 057 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Adult to Adult Living Donor Liver Transplantation Cohort Study (A2ALL) (U01) Apply for RFA DK 09 003 Funding Number: RFA DK 09 003 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $250,000 |
| Ancillary Studies in Immunomodulation Clinical Trials (R01) Apply for RFA AI 08 011 Funding Number: RFA AI 08 011 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| NIDDK Mentored Research Scientist Development Award (K01) Apply for PAR 09 060 Funding Number: PAR 09 060 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| George M. OBrien Urology Research Centers (P50) Apply for RFA DK 08 016 Funding Number: RFA DK 08 016 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Multiethnic Study of Type 2 Diabetes Genes (U01) Apply for RFA DK 09 004 Funding Number: RFA DK 09 004 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $500,000 |
| Limited Competition Continuation of the Clinical Islet Transplantation (CIT) Consortium (U01) Apply for RFA DK 09 501 Funding Number: RFA DK 09 501 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Chronic Kidney Disease Biomarker Discovery and Validation Consortium (U01) Apply for RFA DK 08 015 Funding Number: RFA DK 08 015 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $500,000 |
| Pilot and Feasibility Clinical Research Grants in Kidney or Urologic Diseases (R21) Apply for PAR 09 077 Funding Number: PAR 09 077 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $200,000 |
| Small Business Innovation Research Competing Renewal Awards for Biomedical and Behavior Research Tools (SBIR R44) Apply for PA 08 115 Funding Number: PA 08 115 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Diabetes Research Centers (P30, P60) Apply for RFA DK 08 008 Funding Number: RFA DK 08 008 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
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