Opportunity Information: Apply for PAR 18 012

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health (NIH), is soliciting investigator-initiated Program Project Grant (P01) applications under the opportunity titled "NIDDK Program Projects (P01 Clinical Trial Optional)" (Funding Opportunity Number PAR-18-012). This mechanism is meant for large, coordinated research programs that bring together multiple interrelated projects under a single overarching theme, typically supported by shared cores and a unifying scientific vision. The "clinical trial optional" label signals that applicants may propose studies that include clinical trials, but a clinical trial is not required; proposals can be fully basic, translational, clinical, or a mix, as long as the overall program is cohesive and aligned with NIDDK priorities.

The scientific scope is broad but mission-driven. NIDDK is looking for programs that advance understanding, prevention, treatment, and cures across its major disease areas: diabetes; selected endocrine and metabolic diseases; obesity; digestive diseases and nutrition; and kidney, urologic, and hematologic diseases. Applications can include new approaches and innovative strategies, and they can involve clinical research where appropriate. In practice, a competitive P01 typically demonstrates clear synergy across projects, where the combined program accomplishes more than the individual projects could do separately, and where cores (for example, biostatistics, clinical coordination, biomarkers, or shared technology) meaningfully accelerate progress across the entire program.

This opportunity is categorized as a discretionary grant under NIH, within the activity areas of Food and Nutrition and Health, and is associated with CFDA number 93.847. The applicant pool is intentionally wide. Eligible applicants include many types of U.S.-based organizations and government entities such as state, county, city or township governments, special district governments, and independent school districts; public and state-controlled institutions of higher education and private institutions of higher education; federally recognized Native American tribal governments and certain tribal organizations; public housing authorities/Indian housing authorities; and a variety of nonprofit organizations (both 501(c)(3) and non-501(c)(3)). For-profit organizations (other than small businesses) and small businesses are also listed as eligible, along with other organizations that meet NIH eligibility rules. The announcement also explicitly highlights eligibility for several mission-relevant institution types and community-oriented entities, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Foreign eligibility is limited in a way that is typical for many NIH opportunities. Non-domestic (non-U.S.) entities are not eligible to apply as the primary applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components may be included when allowed under the NIH Grants Policy Statement, meaning a U.S. applicant can propose certain project elements to be conducted abroad if they are well-justified, clearly defined as foreign components, and compliant with NIH policy.

From an administrative standpoint, the source information lists the original closing date as May 7, 2019, with a creation date of October 30, 2017. The listed award ceiling is $6,250,000, indicating the maximum amount anticipated per award under this announcement (actual budgets are typically determined by project scope, NIH policy, and NIDDK program considerations). The number of expected awards is not specified in the provided data, which often means awards depend on available appropriations and the quality of applications received.

Overall, this FOA is designed for research teams that can organize a multi-project program around a central set of questions or solutions that fit squarely within NIDDKs disease portfolio. Strong applications generally make a compelling case for why a P01 structure is necessary, show tight scientific integration across projects, include shared cores that clearly add value, and outline a program capable of producing advances that meaningfully move the field toward improved prevention, treatment, and, where feasible, cures.

  • The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "NIDDK Program Projects (P01 Clinical Trial Optional)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
  • This funding opportunity was created on 2017-10-30.
  • Applicants must submit their applications by 2019-05-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Each selected applicant is eligible to receive up to $6,250,000.00 in funding.
  • Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), 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, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
Apply for PAR 18 012

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Frequently Asked Questions (FAQs)

What is this funding opportunity?

This opportunity is the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Program Projects grant mechanism, titled "NIDDK Program Projects (P01 Clinical Trial Optional)" under Funding Opportunity Number PAR-18-012. It solicits investigator-initiated Program Project Grant (P01) applications through the National Institutes of Health (NIH).

What type of grant mechanism is a P01 Program Project Grant?

A P01 is intended for large, coordinated research programs that bring together multiple interrelated research projects under a single overarching theme. These programs are typically supported by shared cores and a unifying scientific vision, with an emphasis on synergy across projects.

What does "clinical trial optional" mean for this FOA?

"Clinical trial optional" means applicants may propose studies that include clinical trials, but proposing a clinical trial is not required. Applications can be basic, translational, clinical, or a combination, as long as the overall program is cohesive and aligned with NIDDK priorities.

What scientific areas does NIDDK want to support through this P01?

NIDDK is seeking programs that advance understanding, prevention, treatment, and cures in its mission areas, including: diabetes; selected endocrine and metabolic diseases; obesity; digestive diseases and nutrition; and kidney, urologic, and hematologic diseases.

Is the scientific scope narrow or broad?

The scope is broad but mission-driven. Programs may propose new approaches and innovative strategies across NIDDK disease areas, including clinical research where appropriate, as long as the overall program remains cohesive.

What makes a P01 application competitive under this announcement?

A competitive P01 typically shows clear synergy across projects, meaning the combined program can accomplish more than the individual projects could do separately. Strong applications also show tight scientific integration, a clear central theme, and cores that meaningfully accelerate progress across the program.

What are "cores" in a P01, and what kinds are mentioned here?

Cores are shared resources or services that support multiple projects within the overall program. Examples mentioned include biostatistics, clinical coordination, biomarkers, or shared technology cores, where the core functions add value across the entire P01.

Who is sponsoring and administering this opportunity?

The opportunity is sponsored by NIDDK, which is part of NIH.

Is this an investigator-initiated opportunity?

Yes. The announcement is described as soliciting investigator-initiated P01 applications, meaning applicants propose the scientific program and overall structure within NIDDKs mission scope.

What is the CFDA number associated with this opportunity?

The associated CFDA number listed is 93.847.

How is this opportunity categorized in terms of grant type?

It is categorized as a discretionary grant under NIH.

What activity areas are associated with this opportunity?

The source information associates this opportunity with the activity areas of Food and Nutrition and Health.

Which organizations are eligible to apply?

The eligible applicant pool is broad and includes many U.S.-based organizations and government entities, such as state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and certain tribal organizations; public housing authorities/Indian housing authorities; and nonprofit organizations (both 501(c)(3) and non-501(c)(3)). For-profit organizations (other than small businesses) and small businesses are also listed as eligible, along with other organizations that meet NIH eligibility rules.

Are community-oriented or mission-relevant institution types explicitly included?

Yes. The announcement explicitly highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Can a foreign (non-U.S.) organization apply as the primary applicant?

No. Non-domestic (non-U.S.) entities are not eligible to apply as the primary applicant organization under this opportunity.

Can a non-U.S. component of a U.S. organization apply?

No. Non-domestic components of U.S. organizations are also not eligible to apply.

Are foreign components allowed in any form?

Yes, in a limited way. A U.S. applicant may include foreign components when allowed under the NIH Grants Policy Statement. In that case, the foreign component should be well-justified, clearly defined as a foreign component, and compliant with NIH policy.

What is the maximum award amount listed for this opportunity?

The listed award ceiling is $6,250,000, described as the maximum amount anticipated per award under this announcement. Actual budgets are typically determined by project scope, NIH policy, and NIDDK program considerations.

How many awards does NIDDK expect to make?

The number of expected awards is not specified in the provided information. In practice, that often means awards depend on available appropriations and the quality of applications received.

What are the key dates provided for this opportunity?

The source information lists a creation date of October 30, 2017, and an original closing date of May 7, 2019.

Does the program need to be entirely clinical, entirely basic, or can it mix approaches?

The program can be fully basic, translational, clinical, or a mix. The main requirement described is that the overall program is cohesive and aligned with NIDDK priorities.

What is the central idea behind using a P01 structure instead of separate projects?

The P01 structure is intended for a coordinated, multi-project program organized around a central theme, where integration and shared resources (cores) allow the overall program to achieve more than a collection of separate, standalone projects.

What should applicants emphasize about integration and cohesion?

Applicants are generally expected to present a unifying scientific vision, interrelated projects under a single theme, and meaningful shared cores that accelerate progress across the full program rather than supporting isolated efforts.

Where should a proposed program fit scientifically to be responsive?

Based on the description provided, a responsive program should fit squarely within NIDDKs disease portfolio (diabetes; selected endocrine and metabolic diseases; obesity; digestive diseases and nutrition; kidney, urologic, and hematologic diseases) and aim to advance understanding, prevention, treatment, and cures.

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Applicants who have applied for this opportunity (PAR 18 012) also looked into and applied for these:

Funding Opportunity
Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01 Clinical Trial Optional) Apply for PAR 18 042

Funding Number: PAR 18 042
Agency: National Institutes of Health
Category: Food and Nutrition, Health
Funding Amount: Case Dependent
Metabolic Contributions to the Neurocognitive Complications of Diabetes: Ancillary Studies (R01 Clinical Trial Optional) Apply for PAR 18 051

Funding Number: PAR 18 051
Agency: National Institutes of Health
Category: Food and Nutrition, Health
Funding Amount: Case Dependent
Secondary Analyses in Obesity, Diabetes and Digestive and Kidney Diseases (R21 Clinical Trial Optional) Apply for PA 18 052

Funding Number: PA 18 052
Agency: National Institutes of Health
Category: Food and Nutrition, Health
Funding Amount: $200,000
Pilot and Feasibility Clinical Research Grants in Kidney Diseases (R21 Clinical Trial Optional) Apply for PAR 18 100

Funding Number: PAR 18 100
Agency: National Institutes of Health
Category: Food and Nutrition, Health
Funding Amount: $200,000
Pilot and Feasibility Clinical and Translational Research Studies in Digestive Diseases and Nutrition (R21 Clinical Trial Optional) Apply for PA 18 099

Funding Number: PA 18 099
Agency: National Institutes of Health
Category: Food and Nutrition, Health
Funding Amount: $200,000
Pilot and Feasibility Clinical Research Grants in Urologic Disorders (R21 Clinical Trial Optional) Apply for PAR 18 101

Funding Number: PAR 18 101
Agency: National Institutes of Health
Category: Food and Nutrition, Health
Funding Amount: $200,000
Small Grants for New Investigators to Promote Diversity in Health-Related Research (R21 Clinical Trial Optional) Apply for PAR 18 102

Funding Number: PAR 18 102
Agency: National Institutes of Health
Category: Food and Nutrition, Health
Funding Amount: $125,000
Limited Competition: Small Grant Program for NIDDK K01/K08/K23 Recipients (R03 Clinical Trial Optional) Apply for PAR 18 103

Funding Number: PAR 18 103
Agency: National Institutes of Health
Category: Food and Nutrition, Health
Funding Amount: $50,000
Addressing Health Disparities in NIDDK Diseases (R01 - Clinical Trial Not Allowed) Apply for PA 18 412

Funding Number: PA 18 412
Agency: National Institutes of Health
Category: Food and Nutrition, Health
Funding Amount: Case Dependent
Ancillary Studies to Identify Behavioral and/or Psychological Phenotypes Contributing to Obesity (R01 Clinical Trial Optional) Apply for PAR 18 105

Funding Number: PAR 18 105
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 Clinical Trial Required) Apply for PAR 18 106

Funding Number: PAR 18 106
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 Clinical Trial Required) Apply for PAR 18 107

Funding Number: PAR 18 107
Agency: National Institutes of Health
Category: Food and Nutrition, Health
Funding Amount: $150,000
Elucidating HIV and HIV-treatment Associated Metabolic/Endocrine Dysfunction (R01 Clinical Trial Optional) Apply for RFA DK 17 036

Funding Number: RFA DK 17 036
Agency: National Institutes of Health
Category: Food and Nutrition, Health
Funding Amount: $500,000
Pilot and Feasibility Therapeutic Clinical Trials in Diabetes, and Endocrine and Metabolic Diseases (R21- Clinical Trial Required) Apply for PA 18 405

Funding Number: PA 18 405
Agency: National Institutes of Health
Category: Food and Nutrition, Health
Funding Amount: $200,000
NIDDK Exploratory Clinical Trials for Small Business (R44 Clinical Trial Required) Apply for PAR 18 108

Funding Number: PAR 18 108
Agency: National Institutes of Health
Category: Food and Nutrition, Health
Funding Amount: Case Dependent
NIDDK Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional) Apply for PAR 18 423

Funding Number: PAR 18 423
Agency: National Institutes of Health
Category: Food and Nutrition, Health
Funding Amount: $225,000
NIDDK Multi-Center Clinical Trial Cooperative Agreement (U01 Clinical Trial Required) Apply for PAR 18 415

Funding Number: PAR 18 415
Agency: National Institutes of Health
Category: Food and Nutrition, Health
Funding Amount: Case Dependent
Innovative Research in HIV in Kidney, Urology, and Hematology (R01 Clinical Trial Optional) Apply for RFA DK 17 037

Funding Number: RFA DK 17 037
Agency: National Institutes of Health
Category: Food and Nutrition, Health
Funding Amount: $500,000
NIDDK Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Not Allowed) Apply for PAR 18 414

Funding Number: PAR 18 414
Agency: National Institutes of Health
Category: Food and Nutrition, Health
Funding Amount: Case Dependent
NIDDK Mentored Research Scientist Development Award (K01-Clinical Trial Required) Apply for PAR 18 418

Funding Number: PAR 18 418
Agency: National Institutes of Health
Category: Food and Nutrition, Health
Funding Amount: Case Dependent

 

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