NIDDK Exploratory Clinical Trials for Small Business (R44 Clinical Trial Required) | PAR 18 108

Opportunity Information: Apply for PAR 18 108

The NIDDK Exploratory Clinical Trials for Small Business (R44 Clinical Trial Required), Funding Opportunity Number PAR-18-108, is a National Institutes of Health (NIH) SBIR grant opportunity designed specifically to help eligible small business concerns run investigator-initiated exploratory clinical trials that align with the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). In practical terms, this FOA is meant to give small companies a clear funding path to move a biomedical or health-related product into early-stage clinical testing, especially when that clinical work is necessary to demonstrate feasibility, generate initial human evidence, and reduce the risks that often prevent promising innovations from advancing toward later-phase trials or commercialization.

The scope is intentionally broad as long as the work fits within NIDDK priorities. Proposed clinical trials can focus on products and interventions relevant to diabetes, digestive diseases, kidney and urologic diseases, nutrition-related conditions, and other areas that fall under NIDDKs portfolio. The FOA explicitly allows evaluation of a wide range of intervention types, including drugs and other small molecules, biologics, and medical devices, as well as surgical approaches, behavioral interventions, rehabilitation strategies, or related therapeutic approaches. The emphasis is on exploratory clinical trials, meaning studies that are typically early in the clinical development pathway and aimed at gathering the kind of preliminary clinical data that can justify or shape larger, more definitive trials later on.

This opportunity uses the NIH grant funding mechanism and is categorized as discretionary funding. The eligible applicant pool is centered on small businesses, consistent with SBIR requirements, and the mechanism referenced in the title (R44) indicates a small business clinical trial-related award structure where a clinical trial is required under the terms of this announcement. The activity category listed for this program includes health and food and nutrition, and it is associated with CFDA number 93.847, which corresponds to NIDDK-related assistance listings.

Eligibility rules are strict regarding foreign participation. Non-domestic (non-U.S.) entities, meaning foreign institutions, are not eligible to apply as the applicant organization. Likewise, non-domestic components of U.S. organizations are not eligible to apply. That said, foreign components as defined under the NIH Grants Policy Statement may be permitted in some circumstances, which typically means a U.S. small business may be allowed to include certain well-justified foreign elements in the project (for example, specialized expertise, resources, or patient populations not readily available in the U.S.), but only if consistent with NIH policy and the specific FOA guidance. Applicants are expected to consult the FOA for the detailed eligibility language and requirements, since those details control what is allowable.

Key administrative details provided in the source information include an original closing date of 2019-09-05, a creation date of 2017-11-28, and an agency sponsor of the National Institutes of Health. The listing does not specify an award ceiling or the expected number of awards in the excerpt provided, so those items would need to be confirmed in the full FOA text or related NIH materials. Overall, the program is best understood as a targeted NIH SBIR funding route for small businesses that are ready to test an NIDDK-relevant therapeutic, device, or intervention in an early clinical trial and need federal support to generate initial human evidence to advance development.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "NIDDK Exploratory Clinical Trials for Small Business (R44 Clinical Trial Required)" 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 2017-11-28.
• Applicants must submit their applications by 2019-09-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 18 108

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