Opportunity Information: Apply for RFA DK 12 501
Apply for RFA DK 12 501
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Limited Competition Continuation of the Clinical Islet Transplantation (CIT) Consortium Data Coordinating Center (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 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Jan 13, 2012 and posted on Jan 13, 2012.
- Applicants must submit their applications by Mar 14, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $3,200,000.00 to eligible and selected applicants.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
- Other Eligible Applicants include the following 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 funding opportunity RFA-DK-12-501, titled "Limited Competition Continuation of the Clinical Islet Transplantation (CIT) Consortium Data Coordinating Center (U01)," is a National Institutes of Health (NIH) cooperative agreement intended to continue support for the Data Coordinating Center that manages and coordinates the Clinical Islet Transplantation (CIT) Consortium. The announcement is explicitly limited competition, meaning eligibility to apply is restricted as described in the full FOA, and it is not an open, broadly competed grant. The award mechanism is a U01 cooperative agreement, which typically involves substantial NIH scientific or programmatic involvement in the conduct and oversight of the funded activities compared with a standard research project grant.
Programmatically, the purpose is continuity and completion. The CIT Consortium began in 2004 and, by the time of this announcement, had been running eight clinical trials evaluating transplantation of human islets as a therapeutic approach for individuals with type 1 diabetes. Rather than launching a new consortium or an entirely new trial portfolio, this FOA focuses on maintaining ongoing consortium operations, ensuring that current studies can be completed in an orderly and compliant way, and supporting the development of phase III study reports. In practical terms, that implies a strong emphasis on the infrastructure required to finish multi-site clinical research: centralized data management, consistent protocol implementation support, monitoring and quality control, coordination across clinical centers, and timely, accurate reporting of results suitable for later-stage clinical trial documentation.
The opportunity is categorized as discretionary funding and uses the cooperative agreement instrument under NIH activity areas that align with diabetes and related biomedical research. The CFDA numbers listed are 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research), 93.855 (Allergy and Infectious Diseases Research), and 93.856 (Microbiology and Infectious Diseases Research), reflecting the intersecting scientific and clinical issues relevant to islet transplantation, immune response, and infectious disease considerations that can arise in transplant settings. No cost sharing or matching is required, which means applicants are not expected to commit non-federal funds as a condition of the award.
From a funding and timing standpoint, the FOA posted on January 13, 2012, with an application due date of March 14, 2012, and an estimated total funding level of $3,200,000. The archive date listed is April 14, 2012, indicating the opportunity is no longer active and is retained for historical record. Even though it is archived, the details are useful for understanding NIH priorities at the time and the structure of consortium-based clinical trial coordination awards.
Eligibility is constrained and includes important limitations on foreign participation. Non-U.S. (foreign) institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, which generally means certain defined project elements may be carried out abroad under appropriate circumstances and approvals, while the applicant organization itself must be eligible and based in the United States. The listing of "Others (see text field entitled Additional Information on Eligibility for clarification)" signals that the full FOA provides the specific limited-competition eligibility definition, which commonly restricts submission to an incumbent awardee or a small set of invited/qualified entities tied to the existing consortium structure.
Overall, this FOA is best understood as an infrastructure and operations continuation award for a mature, multi-trial clinical consortium focused on human islet transplantation for type 1 diabetes. Its central deliverables are the coordinated management needed to complete ongoing clinical studies and to produce phase III-level reports, which are typically critical for regulatory-quality documentation, publication, and broader dissemination of trial outcomes. For additional official detail, the announcement points to the NIH Grants Guide page at http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-12-501.html and provides NIH Office of Extramural Research (OER) webmaster contacts for access or linking issues (FBOWebmaster@OD.NIH.GOV).
FAQs: RFA-DK-12-501 - Limited Competition Continuation of the Clinical Islet Transplantation (CIT) Consortium Data Coordinating Center (U01)
What is the funding opportunity RFA-DK-12-501?
RFA-DK-12-501 is an NIH cooperative agreement opportunity titled "Limited Competition Continuation of the Clinical Islet Transplantation (CIT) Consortium Data Coordinating Center (U01)." Its purpose is to continue support for the Data Coordinating Center (DCC) that manages and coordinates the Clinical Islet Transplantation (CIT) Consortium.
What does "limited competition" mean for this opportunity?
"Limited competition" means the opportunity is not open to all applicants. Eligibility to apply is restricted as described in the full Funding Opportunity Announcement (FOA). This typically indicates only specific organizations tied to the existing consortium structure (often incumbent or otherwise specifically eligible entities) may apply.
What NIH award mechanism is used (and what does U01 imply)?
The award mechanism is a U01 cooperative agreement. A cooperative agreement generally involves substantial NIH scientific or programmatic involvement in the conduct and oversight of the funded activities, compared with a standard research project grant.
What is the main purpose of this FOA?
The main purpose is continuity and completion of ongoing consortium activities rather than launching a new consortium or new trial portfolio. The FOA emphasizes maintaining operations so current studies can be completed in an orderly and compliant way and supporting development of phase III study reports.
What is the Clinical Islet Transplantation (CIT) Consortium?
The CIT Consortium began in 2004 and, by the time of this announcement, had been running eight clinical trials evaluating transplantation of human islets as a therapeutic approach for individuals with type 1 diabetes.
Is this opportunity focused on starting new clinical trials?
No. Based on the description provided, the FOA focuses on maintaining ongoing consortium operations and completing current studies, including producing phase III study reports, rather than initiating an entirely new set of trials.
What kinds of activities would the Data Coordinating Center be expected to support?
The FOA description points to core infrastructure and operations needed to finish multi-site clinical research, including centralized data management, consistent protocol implementation support, monitoring and quality control, coordination across clinical centers, and timely and accurate reporting suitable for later-stage (phase III) documentation.
What are the key deliverables emphasized in the opportunity?
The central deliverables are coordinated management needed to complete ongoing clinical studies and to produce phase III-level study reports, which are described as important for regulatory-quality documentation, publication, and broader dissemination of trial outcomes.
Which NIH program areas or topics does this opportunity align with?
The opportunity aligns with diabetes and related biomedical research and reflects intersecting issues relevant to islet transplantation, immune response, and infectious disease considerations in transplant settings.
What CFDA numbers are associated with this opportunity?
The CFDA numbers listed are 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research), 93.855 (Allergy and Infectious Diseases Research), and 93.856 (Microbiology and Infectious Diseases Research).
Is cost sharing or matching required?
No. The opportunity specifies that no cost sharing or matching is required, meaning applicants are not expected to commit non-federal funds as a condition of the award.
What is the estimated total funding level for this FOA?
The estimated total funding level listed is $3,200,000.
When was the FOA posted and when was the application due?
The FOA was posted on January 13, 2012, and the application due date was March 14, 2012.
Is this funding opportunity still active?
No. The archive date is April 14, 2012, which indicates the opportunity is no longer active and is retained for historical record.
Who is eligible to apply?
Eligibility is restricted due to the limited-competition nature of the FOA, as described in the full FOA. The listing includes "Others (see text field entitled Additional Information on Eligibility for clarification)," indicating that the detailed limited-competition eligibility definition appears in the full announcement.
Are non-U.S. (foreign) institutions eligible to apply?
No. Non-U.S. (foreign) institutions are not eligible to apply.
Are non-U.S. components of U.S. organizations eligible to apply?
No. Non-U.S. components of U.S. organizations are also not eligible to apply.
Are foreign components allowed at all under this opportunity?
Yes. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. This generally means certain defined project elements may be carried out abroad under appropriate circumstances and approvals, while the applicant organization itself must be eligible and based in the United States.
What does "discretionary funding" indicate here?
The opportunity is categorized as discretionary funding, and it uses the cooperative agreement instrument for consortium-based clinical trial coordination activities.
Where can applicants find the official FOA text and details?
The announcement points to the NIH Grants Guide page at: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-12-501.html.
Who is the contact for access or linking issues related to the FOA webpage?
The NIH Office of Extramural Research (OER) webmaster contact provided for access or linking issues is FBOWebmaster@OD.NIH.GOV.
What is the best overall way to understand this FOA based on the description provided?
This FOA is best understood as an infrastructure and operations continuation award for a mature, multi-trial clinical consortium focused on human islet transplantation for type 1 diabetes, with a strong emphasis on coordinated management to complete ongoing studies and produce phase III-level reports.
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| Funding Opportunity |
|---|
| Nutrition Obesity Research Centers (P30) Apply for RFA DK 12 004 Funding Number: RFA DK 12 004 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $750,000 |
| NIDDK Inflammatory Bowel Disease Genetics Consortium (IBDGC) Genetic Research Centers (GRCs) (U01) Apply for RFA DK 11 032 Funding Number: RFA DK 11 032 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $250,000 |
| Limited Competition for Data Coordinating Center (DCC) for NIDDK Inflammatory Bowel Disease Genetics Consortium (IBDGC) (U01) Apply for RFA DK 11 502 Funding Number: RFA DK 11 502 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $900,000 |
| The Collaborative Islet Transplantation Registry (UC4) Apply for RFA DK 12 002 Funding Number: RFA DK 12 002 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $530,000 |
| NIDDK Short Term Education Program for Underrepresented Persons (STEP UP) (R25) Apply for RFA DK 12 005 Funding Number: RFA DK 12 005 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $158,000 |
| The Human Islet Distribution Coordinating Center (UC4) Apply for RFA DK 12 001 Funding Number: RFA DK 12 001 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $2,000,000 |
| Secondary Analyses in Obesity, Diabetes and Digestive and Kidney Diseases (R21) Apply for PA 12 125 Funding Number: PA 12 125 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $200,000 |
| Pilot and Feasibility Clinical Research Grants in Diabetes, and Endocrine and Metabolic Diseases (R21) Apply for PA 12 157 Funding Number: PA 12 157 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $200,000 |
| Translational Research to Improve Obesity and Diabetes Outcomes (R18) Apply for PAR 12 172 Funding Number: PAR 12 172 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Planning Grants for Translational Research to Improve Obesity and Diabetes Outcomes (R34) Apply for PAR 12 173 Funding Number: PAR 12 173 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $150,000 |
| Promoting Organ and Tissue Donation Among Diverse Populations (R01) Apply for RFA DK 12 006 Funding Number: RFA DK 12 006 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $150,000 |
| Limited Competition for the Continuation of the Halt Polycystic Kidney Disease Trials Data Coordinating Center (DCC) (U01) Apply for RFA DK 12 505 Funding Number: RFA DK 12 505 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) Consortium (U01) Apply for RFA DK 12 502 Funding Number: RFA DK 12 502 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Renal Function and Chronic Kidney Disease in Aging (R01) Apply for PA 12 211 Funding Number: PA 12 211 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| George M. OBrien Kidney Research Core Centers (P30) Apply for RFA DK 12 008 Funding Number: RFA DK 12 008 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $750,000 |
| Research Enhancement for NIDDK Hematology Grantees (Admin Supp) Apply for PA 12 242 Funding Number: PA 12 242 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| New Technologies for the Study of Lymphatics in the Digestive and Urinary Systems (R43/R44) Apply for PA 12 258 Funding Number: PA 12 258 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $150,000 |
| Lymphatics in Health and Disease in the Digestive, Urinary, Cardiovascular and Pulmonary Systems (R01) Apply for PAR 12 259 Funding Number: PAR 12 259 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $250,000 |
| Lymphatics in Health and Disease in the Digestive, Cardiovascular and Pulmonary Systems (R21) Apply for PAR 12 260 Funding Number: PAR 12 260 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $125,000 |
| Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01) Apply for PAR 12 265 Funding Number: PAR 12 265 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
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