NIDDK Program Projects (P01 Clinical Trial Optional) | PAR 18 012

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.

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