Pilot and Feasibility Clinical and Translational Research Studies in Digestive Diseases and Nutrition (R21 Clinical Trial Optional) | PA 18 099

Opportunity Information: Apply for PA 18 099

The National Institutes of Health (NIH) funding opportunity titled "Pilot and Feasibility Clinical and Translational Research Studies in Digestive Diseases and Nutrition (R21 Clinical Trial Optional)" (Funding Opportunity Number PA-18-099) supports early-stage, exploratory projects that test new ideas or generate preliminary evidence in digestive, liver, and nutrition-related diseases. It is designed for pilot and feasibility clinical and translational studies, meaning the emphasis is on smaller, proof-of-concept efforts that can establish whether a novel approach is workable, help refine study methods, and produce the kind of initial data needed to justify a larger, fully powered follow-on study. The mechanism used is an NIH R21 grant, and clinical trials are optional under this announcement, so applicants may propose either clinical trial work (when appropriate and allowed) or other clinical/translational studies that move discoveries toward patient benefit.

The scope centers on digestive and liver diseases and nutrition, fitting within the broader NIH mission areas of health and food/nutrition research (CFDA 93.847). In practical terms, projects under this FOA would typically aim to bridge gaps between basic discoveries and real-world clinical application. That could include testing a new diagnostic approach, exploring biomarkers, piloting an intervention strategy, evaluating feasibility of recruitment or adherence in a target patient population, or validating protocols and outcome measures needed for a later definitive trial. The key theme is feasibility and innovation rather than large-scale confirmation; the R21 format is commonly used for projects where strong rationale exists but more groundwork is needed before launching a major study.

Funding is provided through a discretionary grant program, and the listed award ceiling is $200,000. This ceiling reflects the maximum amount indicated in the source data for an award under this opportunity. The announcement lists an original closing date of August 14, 2018, and a creation date of November 15, 2017, which places it within a past application cycle; anyone interested would generally need to look for a current or reissued version of the FOA or related NIH opportunities, since NIH often updates, reissues, or supersedes announcements over time.

A wide range of U.S.-based applicant organizations are eligible. Eligible applicants include state, county, and local governments (including cities, townships, and special district governments), independent school districts, and public housing authorities/Indian housing authorities. Higher education institutions are eligible across categories, including public and state-controlled institutions of higher education and private institutions of higher education. The FOA also allows nonprofit organizations, both those with IRS 501(c)(3) status and those without 501(c)(3) status (as long as they are not institutions of higher education under those nonprofit categories). For-profit organizations other than small businesses are eligible, as are small businesses. Federally recognized Native American tribal governments are eligible, and the announcement also recognizes additional tribal and community-oriented entities.

The FOA explicitly highlights additional eligible applicant types to encourage broad participation, including Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISISs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible agencies of the federal government; regional organizations; U.S. territories or possessions; and Indian/Native American tribal governments that are other than federally recognized. This emphasis signals an intent to ensure that institutions serving diverse populations and communities can compete for support, which is often important for digestive and liver disease research because disease burden, access to care, and nutrition-related factors can vary substantially across populations.

At the same time, there are clear restrictions related to foreign involvement. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply. In addition, non-domestic components of U.S. organizations are not eligible to apply, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed. In other words, the work supported under this FOA is intended to be conducted entirely within eligible domestic organizational structures without foreign components.

Overall, PA-18-099 is best understood as an NIH opportunity aimed at catalyzing innovative, early-stage clinical and translational research in digestive diseases, liver diseases, and nutrition. It is structured to help investigators and institutions test feasibility, refine clinical research approaches, and build the preliminary platform needed for larger NIH-funded studies, while maintaining domestic eligibility requirements and welcoming a broad range of U.S. organizations, including community-focused and minority-serving institutions.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Pilot and Feasibility Clinical and Translational Research Studies in Digestive Diseases and Nutrition (R21 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 2017-11-15.
• Applicants must submit their applications by 2018-08-14. (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 $200,000.00 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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