Opportunity Information: Apply for PA 15 176
Apply for PA 15 176
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Pilot and Feasibility Clinical Trials in Diabetes, and Endocrine and Metabolic Diseases (R21)" 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 Apr 6, 2015 and posted on Apr 6, 2015.
- 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.)
- The funding agency has allocated a total of $200,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- Eligible applicants include: Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Private institutions of higher education State governments County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Public and State controlled institutions of higher education Small businesses For profit organizations other than small businesses Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) 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) Independent school districts.
- 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.
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Opportunity Summary:
The Pilot and Feasibility Clinical Trials in Diabetes, and Endocrine and Metabolic Diseases (R21) opportunity (Funding Opportunity Number PA 15-176) is a National Institutes of Health discretionary grant program designed to help researchers run early, short-term clinical trials in humans. Its central purpose is to generate the kind of preliminary, real-world evidence needed to justify and properly design a later, larger, and more definitive clinical trial. The focus is on studies that relate to the prevention and/or treatment of diabetes, as well as selected endocrine and genetic metabolic diseases that fall within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), listed under CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).
This announcement is specifically aimed at pilot and feasibility clinical trials, meaning the trials are expected to be limited in scope and duration, but still conducted in humans and structured in a way that meaningfully informs next-step research. In practical terms, the program is meant to support work such as testing whether an intervention can be delivered as planned, assessing participant recruitment and retention strategies, confirming that key measurements and outcomes can be collected reliably, and producing early estimates of effect size or variability. A major theme of the announcement is using these preliminary findings to refine statistical assumptions and power calculations so that a subsequent, larger clinical trial is appropriately sized and designed. The larger goal is to set up future studies that can credibly influence clinical practice, patient care decisions, and measurable health outcomes.
The funding mechanism is an R21, which is commonly used by NIH for exploratory or developmental projects. For this particular announcement, the award ceiling is listed at $200,000, with an estimated total funding amount of $200,000, and there is no cost-sharing or matching requirement. The activity categories associated with the listing include Food and Nutrition and Health, reflecting the broad relevance of diabetes and metabolic disease research to both clinical medicine and public health.
Eligibility is broad and includes a wide range of organizations and institutions. Eligible applicants include public and private institutions of higher education (including public/state-controlled institutions), nonprofit organizations (both with and without 501(c)(3) status), small businesses, for-profit organizations other than small businesses, and multiple levels of government such as state, county, city or township, special district governments, and independent school districts. The opportunity also extends to Native American tribal governments (federally recognized) and Native American tribal organizations (other than federally recognized tribal governments), as well as public housing authorities/Indian housing authorities. Beyond these, the announcement explicitly notes additional eligible applicants, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, U.S. territories or possessions, eligible federal agencies, and even non-U.S. entities (foreign organizations), indicating that the program is open to a diverse range of applicants capable of carrying out human clinical research aligned with NIDDK priorities.
In terms of timing and administrative details, the opportunity was posted and created on April 6, 2015, with an original and current closing date listed as May 7, 2018, and an archive date of June 7, 2018. The full announcement was made available through the NIH Grants Guide at the link provided in the source information (http://grants.nih.gov/grants/guide/pa-files/PA-15-176.html). For access or technical issues, the contact route referenced is the NIH Office of Extramural Research (OER) webmaster (FBOWebmaster@OD.NIH.GOV), which is primarily for troubleshooting access or linking problems rather than scientific questions about fit or scope.
Overall, this FOA is best understood as a stepping-stone funding opportunity: it is not meant to bankroll a full-scale, practice-changing clinical trial on its own, but to pay for the early clinical testing needed to show that a larger trial is feasible, to sharpen the trial design, and to produce credible preliminary human data that strengthens the rationale for a subsequent definitive study in diabetes or related endocrine and metabolic diseases under the NIDDK mission.
Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
The opportunity is titled Pilot and Feasibility Clinical Trials in Diabetes, and Endocrine and Metabolic Diseases (R21).
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PA 15-176.
Who is offering this grant?
This is a National Institutes of Health (NIH) discretionary grant program aligned with the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
What is the main purpose of this program?
The central purpose is to support early, short-term clinical trials in humans that generate the kind of preliminary, real-world evidence needed to justify and properly design a later, larger, more definitive clinical trial.
What kind of studies does this FOA support?
This FOA supports pilot and feasibility clinical trials conducted in humans that are limited in scope and duration but structured to meaningfully inform next-step research.
Does the program fund full-scale, definitive clinical trials?
No. The opportunity is described as a stepping-stone and is not intended to bankroll a full-scale, practice-changing clinical trial by itself. It is meant to fund early clinical testing that strengthens the rationale and design for a later definitive study.
What diseases or topic areas are in scope?
The focus is on studies related to the prevention and/or treatment of diabetes and selected endocrine and genetic metabolic diseases that fall within the NIDDK mission.
What does "pilot and feasibility" mean in this announcement?
In practical terms, "pilot and feasibility" refers to human trials designed to answer early implementation and design questions such as whether an intervention can be delivered as planned, whether participants can be recruited and retained, and whether key outcomes can be measured reliably.
What types of questions or outputs are these trials expected to produce?
Examples of the supported outputs include:
- Testing whether an intervention can be delivered as planned
- Assessing recruitment and retention strategies
- Confirming that key measurements and outcomes can be collected reliably
- Producing early estimates of effect size and/or variability
- Refining statistical assumptions and power calculations for a subsequent larger trial
Why are effect size and variability estimates emphasized?
The FOA highlights generating early estimates of effect size or variability to help refine statistical assumptions and power calculations, so a later larger clinical trial can be appropriately sized and designed.
What is the funding mechanism?
The funding mechanism is an R21, commonly used by NIH for exploratory or developmental projects.
What is the maximum award amount mentioned?
The award ceiling is listed as $200,000.
What total funding amount is estimated in the listing?
The estimated total funding amount is listed as $200,000.
Is cost-sharing or matching required?
No. The announcement states there is no cost-sharing or matching requirement.
What activity categories are associated with this opportunity?
The activity categories include Food and Nutrition and Health.
What CFDA program is associated with this opportunity?
The FOA is listed under CFDA 93.847, described as Diabetes, Digestive, and Kidney Diseases Extramural Research.
Who is eligible to apply?
Eligibility is broad and includes many organization types that can carry out human clinical research aligned with NIDDK priorities.
Are universities and colleges eligible?
Yes. Eligible applicants include public and private institutions of higher education, including public/state-controlled institutions.
Are nonprofit organizations eligible?
Yes. Eligible applicants include nonprofit organizations both with and without 501(c)(3) status.
Are for-profit organizations eligible?
Yes. Eligible applicants include small businesses and for-profit organizations other than small businesses.
Are government entities eligible?
Yes. Eligible applicants include multiple levels of government such as state, county, city or township, special district governments, and independent school districts.
Are Native American tribal governments or organizations eligible?
Yes. Eligible applicants include Native American tribal governments (federally recognized) and Native American tribal organizations (other than federally recognized tribal governments).
Are public housing authorities eligible?
Yes. The eligibility list includes public housing authorities/Indian housing authorities.
Are minority-serving institutions (MSIs) mentioned as eligible?
Yes. The announcement explicitly notes eligibility for institutions including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, and related categories.
Are faith-based or community-based organizations eligible?
Yes. The FOA explicitly notes faith-based or community-based organizations as eligible applicants.
Are U.S. territories or possessions eligible?
Yes. The announcement explicitly includes U.S. territories or possessions among additional eligible applicants.
Are federal agencies eligible?
Yes. The announcement notes eligible federal agencies among additional eligible applicants.
Are non-U.S. (foreign) organizations eligible?
Yes. The eligibility description indicates that non-U.S. entities (foreign organizations) are eligible.
When was this opportunity posted?
The opportunity was posted and created on April 6, 2015.
What was the closing date for this opportunity?
The original and current closing date is listed as May 7, 2018.
When was the opportunity archived?
The archive date is listed as June 7, 2018.
Where can applicants find the full announcement?
The full announcement is available through the NIH Grants Guide at: http://grants.nih.gov/grants/guide/pa-files/PA-15-176.html
Who should be contacted for access or technical issues with the announcement link?
For access or technical issues, the referenced contact is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV. The information provided notes this is primarily for troubleshooting access or linking problems rather than scientific fit questions.
What is the intended longer-term impact of projects funded under this FOA?
The intended longer-term goal is to set up future studies that can credibly influence clinical practice, patient care decisions, and measurable health outcomes by improving the feasibility and design of subsequent definitive trials.
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Applicants also applied for:
Applicants who have applied for this opportunity (PA 15 176) also looked into and applied for these:
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| NIDDK Centers for Diabetes Translation Research (P30) Apply for RFA DK 15 003 Funding Number: RFA DK 15 003 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
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| Exploratory Studies for Delineating Microbiome Host Interactions in Obesity, Digestive and Liver Diseases and Nutrition (R21) Apply for RFA DK 15 013 Funding Number: RFA DK 15 013 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $200,000 |
| Exploration of the Roles of Brown and Beige Adipose Tissue in Humans (R01) Apply for RFA DK 15 031 Funding Number: RFA DK 15 031 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
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| Mechanisms Underlying the Contribution of Type 1 Diabetes Risk Associated Variants (DP3) Apply for RFA DK 15 025 Funding Number: RFA DK 15 025 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $600,000 |
| Mouse Metabolic Phenotyping Centers Consortium (U2C) Apply for RFA DK 15 010 Funding Number: RFA DK 15 010 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $750,000 |
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