NIDDK Exploratory Clinical Trials for Small Business (R44) | PAR 17 034

Opportunity Information: Apply for PAR 17 034

The NIDDK Exploratory Clinical Trials for Small Business (R44) opportunity (Funding Opportunity Number PAR-17-034) is an NIH Small Business Innovation Research (SBIR) funding announcement 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, it is meant to give small companies a clear pathway to request NIH grant support for early-stage clinical testing of a product or intervention intended to prevent, diagnose, treat, or manage conditions within NIDDKs core areas, including diabetes, endocrinology and metabolic diseases, digestive diseases, nutrition-related conditions, and kidney, urologic, and hematologic diseases. The award mechanism is an R44 SBIR grant, which generally corresponds to an SBIR Phase II style clinical effort, emphasizing development and translation rather than basic discovery.

The scope is intentionally broad in terms of what can be studied, as long as the work remains tightly connected to NIDDK priorities and represents a product-focused development effort suitable for a small business. Supported trials may evaluate drugs and small molecules, biologics, or medical devices, but the FOA also allows exploratory clinical testing of non-pharmacologic approaches such as surgical interventions, behavioral therapies, rehabilitation strategies, or related therapeutic programs, provided they are structured as a clinical trial and are being advanced toward real-world use. The emphasis on "exploratory" clinical trials signals that the target studies are typically early clinical investigations, often focused on feasibility, initial safety, dose or parameter exploration, usability, proof-of-concept signals, and collection of information needed to justify or design a later, larger pivotal trial. The core idea is to reduce technical and clinical risk so a small business can make informed development decisions and move a promising NIDDK-relevant product toward commercialization and broader clinical adoption.

Eligibility is limited to small businesses, consistent with SBIR program rules. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply under this announcement. However, the FOA notes that "foreign components" as defined by the NIH Grants Policy Statement may be allowed in some cases, meaning certain discrete elements of the project could potentially be carried out abroad if NIH policy permits and if properly justified, but the applicant organization itself must be an eligible U.S. small business and the overall project must remain compliant with NIH SBIR and grants policy requirements. The listing also categorizes the opportunity under discretionary grant funding in the health and food/nutrition activity area (CFDA 93.847), reflecting NIDDKs program portfolio.

From an applicants perspective, the opportunity is best viewed as a funding vehicle for translating a specific intervention into human testing under a controlled clinical protocol, rather than as support for general research. A strong application would typically be expected to present a clear clinical development rationale, a well-defined investigational product or intervention, a feasible and ethically sound clinical protocol, and a plan for how the exploratory trial will generate actionable data that moves the product closer to the next development milestone. Because it is an SBIR mechanism, the proposal is also expected to maintain a commercialization and product-development orientation, explaining the practical path from trial results to subsequent development steps, regulatory considerations where relevant (for example, IND/IDE strategy when applicable), and eventual market impact for patients within NIDDKs mission areas.

Key administrative details in the provided record include the original posting timeframe (Creation Date: 2016-10-27) and an original closing date of 2019-09-05, indicating that this particular FOA record reflects a defined historical application window. No award ceiling or expected number of awards is specified in the excerpted source data, so applicants would typically need to consult the full FOA text for budget guidance, project period expectations, and any institute-specific limits or clinical trial requirements. Overall, the opportunity is structured to help U.S. small businesses generate early clinical evidence for NIDDK-relevant innovations across drugs, biologics, devices, and therapeutic strategies, with the goal of accelerating translation from development to meaningful patient benefit.

• 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)" 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 2016-10-27.
• 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 17 034

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