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.Apply for PAR 18 108
- 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.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
FAQs: NIDDK Exploratory Clinical Trials for Small Business (R44 Clinical Trial Required) - PAR-18-108
What is this grant opportunity?
This is an NIH SBIR funding opportunity from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) titled "NIDDK Exploratory Clinical Trials for Small Business (R44 Clinical Trial Required)." It is designed to help eligible small business concerns run investigator-initiated exploratory clinical trials that fit within NIDDK's mission.
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PAR-18-108.
What type of funding mechanism does this use?
The opportunity uses an NIH grant funding mechanism and is an SBIR opportunity. The mechanism referenced in the title is R44, and a clinical trial is required under this announcement.
Is a clinical trial required to apply under this FOA?
Yes. The title includes "Clinical Trial Required (R44)," indicating that the proposed work must include a clinical trial under the terms of this announcement.
What is the main purpose of this program?
The program provides a funding path for small companies to move biomedical or health-related products into early-stage clinical testing when that clinical work is needed to demonstrate feasibility, generate initial human evidence, and reduce development risk before later-phase trials or commercialization.
What kinds of studies are supported (exploratory vs. definitive trials)?
The emphasis is on exploratory clinical trials. These are typically early in the clinical development pathway and are intended to generate preliminary clinical data that can justify, inform, or shape larger and more definitive trials later.
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH), specifically NIDDK.
Who is eligible to apply?
The eligible applicant pool is centered on small businesses, consistent with SBIR requirements, and the FOA is described as supporting eligible small business concerns conducting investigator-initiated exploratory clinical trials.
What disease and research areas are in scope?
The scope is broad as long as the project fits within NIDDK priorities. Examples given include diabetes, digestive diseases, kidney and urologic diseases, nutrition-related conditions, and other topics within NIDDK's portfolio.
What types of products or interventions can be evaluated in the clinical trial?
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, provided they align with NIDDK priorities.
Does the FOA support only therapeutics and devices, or also non-product interventions?
It supports a broad range of interventions. In addition to therapeutics and devices, the description also includes surgical approaches, behavioral interventions, and rehabilitation strategies as allowable intervention types.
Is this program intended for early-stage clinical testing?
Yes. The stated intent is to fund early-stage (exploratory) clinical testing that helps demonstrate feasibility and generates initial human evidence.
Is this funding considered discretionary?
Yes. The opportunity is categorized as discretionary funding.
Are foreign (non-U.S.) organizations eligible to apply as the applicant?
No. Non-domestic (non-U.S.) entities are not eligible to apply as the applicant organization.
Can a non-domestic component of a U.S. organization apply?
No. Non-domestic components of U.S. organizations are not eligible to apply.
Are any foreign components allowed as part of the project?
Potentially. Foreign components (as defined under the NIH Grants Policy Statement) may be permitted in some circumstances. The description notes that a U.S. small business may be allowed to include well-justified foreign elements (for example, specialized expertise, resources, or patient populations not readily available in the U.S.) if consistent with NIH policy and the specific FOA guidance.
Where should applicants look for the controlling eligibility details about foreign participation?
Applicants are expected to consult the full FOA for detailed eligibility language and requirements, since those details control what is allowable.
What is the CFDA number associated with this program?
The CFDA number listed is 93.847, corresponding to NIDDK-related assistance listings.
What activity categories are associated with this program?
The activity category listed includes health and food and nutrition.
What are the key dates provided in the listing?
The source information provides a creation date of 2017-11-28 and an original closing date of 2019-09-05.
Does the provided excerpt list an award ceiling or number of awards?
No. The excerpt does not specify an award ceiling or the expected number of awards. Those items would need to be confirmed in the full FOA text or related NIH materials.
What does "investigator-initiated" mean in this context?
Based on the description, it means the small business proposes and leads its own exploratory clinical trial idea (as opposed to conducting a trial designed by the agency), as long as the trial aligns with NIDDK's mission and priorities.
What is the overall best-fit use case for this FOA?
This FOA is best suited for an eligible small business that is ready to test an NIDDK-relevant therapeutic, device, or other intervention in an early clinical trial and needs federal support to generate initial human evidence to advance development toward later-stage trials or commercialization.
Browse more opportunities from the same category: Food and Nutrition, Health
Next opportunity: Sleep disorders and circadian clock disruption in Alzheimers disease and other dementias of aging (R01 Clinical Trial Not Allowed)
Previous opportunity: GDL Center for Digital Development
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for PAR 18 108
Applicants also applied for:
Applicants who have applied for this opportunity (PAR 18 108) also looked into and applied for these:
| Funding Opportunity |
|---|
| 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 |
| NIDDK Mentored Research Scientist Development Award (K01-No Independent Clinical Trials) Apply for PAR 18 419 Funding Number: PAR 18 419 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| High Impact, Interdisciplinary Science in NIDDK Research Areas (RC2 Clinical Trial Optional) Apply for PAR 18 111 Funding Number: PAR 18 111 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Academic Research Enhancement Award in Diseases within the Mission of NIDDK (R15 - Clinical Trial Required) Apply for PA 18 495 Funding Number: PA 18 495 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Microphysiological Systems (MPS) for Modeling Diabetes (UG3/UH3 Clinical Trial Not Allowed) Apply for RFA DK 17 035 Funding Number: RFA DK 17 035 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Ancillary Studies to the NIDDK Inflammatory Bowel Disease Genetics Consortium (R21 - Clinical Trial Optional) Apply for RFA DK 17 018 Funding Number: RFA DK 17 018 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $150,000 |
| Ancillary Studies to the NIDDK Inflammatory Bowel Disease Genetics Consortium (R01- Clinical Trial Optional) Apply for RFA DK 17 017 Funding Number: RFA DK 17 017 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $200,000 |
| Support for Small Business Innovation Research to Develop New Open and Closed-Loop Automated Technologies for Better Type 1 Diabetes Therapy and Monitoring (SBIR) (R43/R44- Clinical Trial Not Allowed) Apply for RFA DK 17 029 Funding Number: RFA DK 17 029 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Development of New Technologies and Bioengineering Solutions for the Advancement of Cell Replacement Therapies for Type 1 Diabetes (R43/44 Clinical Trial Not Allowed) Apply for RFA DK 17 030 Funding Number: RFA DK 17 030 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Underactive Bladder and Detrusor Activity in Aging (R01 Clinical Trial Optional) Apply for PA 18 570 Funding Number: PA 18 570 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Pilot and Feasibility Studies of HIV and Animal Models for HIV Infection within the Mission of NIDDK (R21 Clinical Trial Optional) Apply for PA 18 615 Funding Number: PA 18 615 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $200,000 |
| Limited Competition for the Continuation of the Clinical Centers for The Environmental Determinants of Diabetes in the Young (TEDDY) Study (U01 Clinical Trial Not Allowed ) Apply for RFA DK 17 511 Funding Number: RFA DK 17 511 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $1,100,000 |
| Mass Spectrometric Assays for the Reliable and Reproducible Detection of Proteins/Peptides of Importance in Type 1 Diabetes Research (U01 Clinical Trial Not Allowed) Apply for RFA DK 17 019 Funding Number: RFA DK 17 019 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $350,000 |
| Immune System Engineering For Targeted Tolerance in Type 1 Diabetes (R01 Clinical Trial Not Allowed) Apply for RFA DK 17 020 Funding Number: RFA DK 17 020 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $300,000 |
| Treating Diabetes Distress to Improve Glycemic Outcomes in Type 1 Diabetes (R01 Clinical Trial Required) Apply for RFA DK 17 028 Funding Number: RFA DK 17 028 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $500,000 |
| The Characterization and Discovery of Novel Autoantigens and Epitopes in Type 1 Diabetes (R01 Clinical Trial Optional) Apply for RFA DK 17 031 Funding Number: RFA DK 17 031 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "PAR 18 108", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.