Opportunity Information: Apply for RFA DK 11 010
Apply for RFA DK 11 010
- The National Institutes of Health in the food and nutrition health income security and social services sector is offering a public funding opportunity titled "Clinical Trial Planning Grants in Type 1 Diabetes (R34)" 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 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders 93.865 Child Health and Human Development Extramural Research 93.887 Health Care and Other Facilities.
- This funding opportunity was created on May 2, 2011 and posted on May 2, 2011.
- Applicants must submit their applications by Mar 15, 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 $1,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $100,000.00 in funding.
- Eligible applicants include: Special district governments Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) State governments City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Small businesses County governments Public and State controlled 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) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non U.S.) components of U.S. Organizations are allowed.
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Opportunity Summary:
The Clinical Trial Planning Grants in Type 1 Diabetes (R34) opportunity (Funding Opportunity Number RFA-DK-11-010) is a discretionary NIH grant designed specifically to support the early, structured planning work needed to launch a full clinical trial in type 1 diabetes. The central idea is to fund the preparatory phase so that investigators can assemble everything required for a rigorous, feasible, and well-governed clinical trial that is ready to start. These planning awards are meant to be a bridge to a subsequent trial that tests an intervention aimed at improving glycemic control and/or treating, preventing, or reducing complications of type 1 diabetes. NIH frames the goal in very practical terms: if the future trial is successful, the findings should matter to real-world clinical management and be usable right away in the United States, rather than remaining purely theoretical or limited to niche settings.
A key boundary of this FOA is what it is not meant to do. It is not intended for validating brand-new technologies or for testing new therapeutics. Instead, it emphasizes interventions that are closer to being ready for clinical implementation, where the main remaining hurdles are trial design, operational readiness, and the sort of detailed pre-trial decisions that determine whether a multi-site study can actually recruit, retain participants, measure outcomes consistently, and produce interpretable results. In practice, that means the planning grant would support activities like finalizing the protocol and statistical analysis plan, establishing recruitment and retention strategies, refining eligibility criteria, selecting endpoints and outcome measures, building data and safety oversight processes, setting up quality control and data management systems, addressing human subjects and regulatory requirements, coordinating clinical sites, and producing the materials and infrastructure needed to submit and conduct a full-scale clinical trial.
Financially, the FOA lists an estimated total funding amount of $1,000,000 and an award ceiling of $100,000, with no cost-sharing or matching requirement. The opportunity was posted May 2, 2011, with an original and current closing date of March 15, 2012, and an archive date of April 15, 2012. The funding instrument is a grant, and the activity spans multiple program areas reflected in the CFDA numbers provided, including 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research), 93.853 (Neurosciences and Neurological Disorders Extramural Research), 93.865 (Child Health and Human Development Extramural Research), and 93.887 (Health Care and Other Facilities). This mix signals that, while the focus is type 1 diabetes, the research planning could touch related complications or care delivery contexts that overlap with neurology, child health, and health care infrastructure.
Eligibility is broad across U.S.-based organizations and governmental units. Eligible applicants include public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3) entities), for-profit organizations (other than small businesses are explicitly listed, and small businesses are also included), and a wide range of government entities such as state, county, city or township governments, special district governments, and independent school districts. The FOA also highlights eligibility for various mission-focused institutions and community-based organizations, including Historically Black Colleges and Universities (HBCUs), Hispanic Serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), and faith-based or community-based organizations, as well as eligible federal agencies and regional organizations. Non-domestic (non-U.S.) entities are not eligible to apply, but foreign components of U.S. organizations are allowed, which can matter for trials that require certain international coordination while remaining U.S.-led and U.S.-applicable.
The administering agency is the National Institutes of Health. The FOA is positioned as a planning mechanism that should result in a well-justified, operationally sound clinical trial proposal that targets meaningful improvements in type 1 diabetes management. The overall emphasis is on readiness and practicality: planning work that reduces avoidable risk, sharpens the scientific and operational rationale, and sets the stage for a clinical trial whose outcomes can translate directly into improved care. For applicants needing the full announcement details, the FOA provides an NIH Grants Guide link (http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-11-010.html) and lists NIH Office of Extramural Research (OER) webmaster contacts for access or linking issues (FBOWebmaster@OD.NIH.GOV).
Frequently Asked Questions (FAQs): Clinical Trial Planning Grants in Type 1 Diabetes (R34)
1) What is this funding opportunity?
This opportunity is the NIH Clinical Trial Planning Grants in Type 1 Diabetes (R34) funding opportunity, Funding Opportunity Number (FON) RFA-DK-11-010. It is a discretionary NIH grant designed to support structured, early planning work needed to launch a full clinical trial in type 1 diabetes.
2) What is the main purpose of an R34 planning grant under this FOA?
The purpose is to fund the preparatory phase so investigators can assemble the key scientific, operational, and governance elements required for a rigorous and feasible clinical trial. The planning award is intended to serve as a bridge to a subsequent full clinical trial that tests an intervention relevant to type 1 diabetes care.
3) What kind of future study is this planning grant meant to lead to?
The planning work should position a later clinical trial that tests an intervention aimed at improving glycemic control and/or treating, preventing, or reducing complications of type 1 diabetes.
4) What does NIH mean by focusing on practical and real-world impact?
NIH frames the goal in practical terms: if the future trial is successful, the findings should be relevant to real-world clinical management and usable right away in the United States, rather than staying theoretical or only applicable in narrow or niche settings.
5) What is this FOA not intended to support?
This FOA is not intended for validating brand-new technologies or for testing new therapeutics. It emphasizes interventions that are closer to readiness for clinical implementation, where the main remaining challenges are trial design, operational readiness, and detailed pre-trial decision-making.
6) What types of activities can the planning grant support?
Based on the FOA description, supported planning activities can include:
- Finalizing the clinical trial protocol
- Developing the statistical analysis plan
- Establishing recruitment and retention strategies
- Refining eligibility criteria
- Selecting endpoints and outcome measures
- Building data and safety oversight processes
- Setting up quality control procedures
- Designing data management systems
- Addressing human subjects protections and regulatory requirements
- Coordinating clinical sites (including multi-site planning)
- Producing materials and infrastructure needed to submit and conduct a full-scale clinical trial
7) Is this grant meant to pay for conducting the full clinical trial?
No. The FOA is described as supporting the early planning and readiness phase. The intent is to prepare for a subsequent full clinical trial, not to fund the full execution of the trial itself.
8) What is the total estimated amount of funding available?
The FOA lists an estimated total funding amount of $1,000,000.
9) What is the maximum award amount per grant?
The FOA lists an award ceiling of $100,000.
10) Is cost-sharing or matching required?
No. The FOA states there is no cost-sharing or matching requirement.
11) Who is the administering agency?
The administering agency is the National Institutes of Health (NIH).
12) What is the funding instrument and activity type?
The funding instrument is a grant. The opportunity is specifically framed as an NIH planning mechanism (R34) for clinical trial readiness in type 1 diabetes.
13) When was this opportunity posted and when did it close?
The FOA was posted on May 2, 2011. The original and current closing date is March 15, 2012.
14) What is the archive date and what does it imply?
The archive date is April 15, 2012. This typically indicates the opportunity has been archived after the closing period and is no longer active for new submissions under that specific announcement.
15) What CFDA program areas are associated with this FOA?
The FOA lists multiple CFDA numbers, including:
- 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research)
- 93.853 (Neurosciences and Neurological Disorders Extramural Research)
- 93.865 (Child Health and Human Development Extramural Research)
- 93.887 (Health Care and Other Facilities)
This mix suggests the planning work, while centered on type 1 diabetes, may involve related complications, child health considerations, neurological overlaps, and/or care delivery and infrastructure contexts.
16) What types of organizations are eligible to apply?
Eligibility is broad across U.S.-based organizations and governmental units. The FOA lists eligible applicants that include public and private institutions of higher education; nonprofits (including 501(c)(3) and non-501(c)(3) organizations); for-profit organizations; small businesses; and multiple government entities such as state, county, city or township governments, special district governments, and independent school districts.
17) Are minority-serving and community-based institutions eligible?
Yes. The FOA specifically highlights eligibility for institutions and organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic Serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), faith-based organizations, and community-based organizations.
18) Are federal agencies eligible to apply?
Yes. The FOA indicates eligible federal agencies and regional organizations are included among eligible applicants.
19) Are non-U.S. (foreign) organizations eligible to apply?
No. The FOA states that non-domestic (non-U.S.) entities are not eligible to apply.
20) Can a U.S. applicant include foreign components?
Yes. While non-U.S. organizations cannot apply directly, the FOA allows foreign components of U.S. organizations. This may be relevant for planning trials that require some level of international coordination while remaining U.S.-led and intended to be applicable in the United States.
21) What is the central theme NIH is looking for in planning proposals?
The central theme is readiness and practicality. The planning work should reduce avoidable risk, strengthen the scientific and operational rationale, and produce a well-justified, operationally sound clinical trial proposal that can move forward efficiently.
22) Where can applicants find the full FOA announcement?
The FOA provides an NIH Grants Guide link: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-11-010.html
23) Who should be contacted for access or linking issues related to the announcement?
The FOA lists NIH Office of Extramural Research (OER) webmaster contact information for access or linking issues: FBOWebmaster@OD.NIH.GOV
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