Opportunity Information: Apply for RFA HD 19 006
The Non-Invasive Diagnostics to Improve Gynecologic Health (R43/R44 - Clinical Trial Optional) funding opportunity (RFA-HD-19-006) is an NIH small business grant program focused on speeding up and improving how common gynecologic conditions are diagnosed. Its central goal is to push forward practical, clinically relevant diagnostic tools and approaches that can identify endometriosis, adenomyosis, and/or uterine fibroids without relying on highly invasive procedures. The announcement emphasizes technologies that can reduce the long delays many patients experience before getting a correct diagnosis, while also improving the overall experience of care by making testing safer, more convenient, more accessible, and potentially less expensive.
This opportunity uses the SBIR/STTR-style R43/R44 mechanism, meaning it is specifically designed for small businesses rather than universities or large health systems applying on their own. The intent is not just early exploration, but development and validation work that moves a promising diagnostic concept toward real-world use. NIH is explicitly encouraging small companies to collaborate closely with scientists and clinicians who work in gynecologic health, reflecting the expectation that successful projects will be grounded in clinical reality, use appropriate patient samples or clinical reference standards, and be designed with a clear path to adoption in healthcare settings. The "Clinical Trial Optional" label signals that applicants may propose studies that include clinical trial elements if they are needed for validation, but a clinical trial is not automatically required for every project; the appropriate study design depends on the technology and development stage.
From a technical standpoint, the FOA is centered on non-invasive diagnostics, which generally includes approaches that avoid surgery or other highly invasive procedures currently associated with definitive diagnosis in some conditions (for example, laparoscopy in endometriosis). While the announcement does not limit applicants to specific modalities, the scope is aligned with innovations such as biomarker-based tests (for example, blood, urine, saliva, menstrual effluent), advanced imaging or image analysis approaches, sensor-based methods, computational or AI-assisted diagnostic algorithms, or multi-modal tools that combine data sources to improve accuracy and usability. Across these possibilities, NIH is looking for projects that can demonstrate credible performance and clinical utility, meaning the technology should aim to produce actionable diagnostic information in a way that is realistic for patients and clinicians to use.
Eligibility is limited to small businesses, and the FOA is clear about restrictions on foreign involvement at the applicant level. Non-U.S. entities (foreign institutions) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply under this opportunity. However, foreign components, as NIH defines them in the NIH Grants Policy Statement, may be allowed in some circumstances, which typically means a U.S. applicant might justify limited foreign work if it is essential and cannot be performed domestically, subject to NIH approval and the specific conditions in the full announcement.
Administratively, this is a discretionary grant under the health-related assistance listing (CFDA 93.865) and is offered by the National Institutes of Health. The opportunity was created on December 14, 2017, with an original closing date of March 30, 2018. In practical terms, applicants would be expected to propose a development plan consistent with the R43/R44 pathway, where earlier-phase work supports feasibility and prototype development and later-phase work supports further development and validation steps aimed at commercialization and clinical uptake. Overall, the announcement targets a clear public health need: better, faster, and less burdensome diagnosis of endometriosis, adenomyosis, and uterine fibroids, with small businesses positioned as the engine to translate new diagnostic ideas into usable products.Apply for RFA HD 19 006
- The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Non-Invasive Diagnostics to Improve Gynecologic Health (R43/R44 - Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
- This funding opportunity was created on 2017-12-14.
- Applicants must submit their applications by 2018-03-30. (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:
Frequently Asked Questions (FAQs)
What is the Non-Invasive Diagnostics to Improve Gynecologic Health funding opportunity (RFA-HD-19-006)?
This is an NIH small business funding opportunity that supports the development and validation of practical, clinically relevant, non-invasive diagnostic tools for common gynecologic conditions. The goal is to improve how endometriosis, adenomyosis, and/or uterine fibroids are identified, with an emphasis on approaches that avoid highly invasive procedures and shorten the long delays many patients face before receiving an accurate diagnosis.
Which NIH mechanism does this opportunity use (R43/R44)?
The opportunity uses an SBIR/STTR-style R43/R44 mechanism. It is specifically designed for small businesses and supports a pathway that typically starts with earlier-phase feasibility and prototype development and progresses to later-phase development and validation work aimed at real-world clinical use and commercialization.
Who is eligible to apply?
Eligibility is limited to small businesses. The opportunity is not intended for universities or large health systems to apply on their own (though collaboration with such groups can be part of a small business-led application).
Are non-U.S. (foreign) organizations eligible to apply?
No. Non-U.S. entities (foreign institutions) are not eligible to apply under this opportunity.
Can a U.S. organization include non-U.S. components in the application?
Non-U.S. components of U.S. organizations are not eligible to apply under this opportunity. However, the announcement notes that foreign components (as defined by NIH policy) may be allowed in some circumstances if they are justified as essential and cannot be performed domestically, subject to NIH approval and the conditions in the full announcement.
What health conditions are targeted by this FOA?
The FOA targets diagnostic improvements for endometriosis, adenomyosis, and uterine fibroids. Proposed technologies may address one condition or more than one, as long as they align with the FOA's purpose of improving diagnosis in clinically meaningful ways.
What does "non-invasive diagnostics" mean in the context of this opportunity?
In this FOA, non-invasive diagnostics generally refer to approaches intended to avoid surgery or other highly invasive procedures that may currently be associated with definitive diagnosis for certain conditions (for example, laparoscopy in endometriosis). The focus is on tools that can deliver actionable diagnostic information with less burden on patients.
Are clinical trials required?
No. The FOA is labeled "Clinical Trial Optional," meaning applicants may propose studies that include clinical trial elements if needed for validation, but a clinical trial is not automatically required for every project. The appropriate study design depends on the technology and its stage of development.
What kinds of technologies or approaches are in scope?
The FOA does not restrict applicants to a single modality. Examples aligned with the scope include biomarker-based tests (such as blood, urine, saliva, or menstrual effluent), advanced imaging or image analysis approaches, sensor-based methods, computational or AI-assisted diagnostic algorithms, and multi-modal tools that combine multiple data sources to improve accuracy and usability.
What is NIH looking for beyond a promising idea?
NIH is emphasizing development and validation work that moves a diagnostic concept toward real-world clinical use. Projects are expected to be grounded in clinical reality, use appropriate patient samples or clinical reference standards, and be designed with a clear path to adoption in healthcare settings.
How does this FOA aim to improve patient care?
The FOA emphasizes reducing long diagnostic delays and improving the overall experience of care by making testing safer, more convenient, more accessible, and potentially less expensive, while still delivering credible diagnostic performance and clinical utility.
What does "clinical utility" imply for proposed diagnostics?
Within the FOA's framing, clinical utility means the technology should aim to produce actionable diagnostic information in a way that is realistic for clinicians and patients to use. This includes credible performance and a practical fit in healthcare workflows.
Is collaboration encouraged?
Yes. NIH explicitly encourages small companies to collaborate closely with scientists and clinicians who work in gynecologic health. This reflects an expectation that strong projects will incorporate clinical insight and use appropriate samples and reference standards.
What is the assisting listing (CFDA) number associated with this opportunity?
The opportunity is listed under CFDA 93.865 as a health-related assistance listing.
Which federal agency is offering the grant?
The grant opportunity is offered by the National Institutes of Health (NIH).
What type of grant is this?
It is described as a discretionary grant.
When was this funding opportunity created and when did it originally close?
The opportunity was created on December 14, 2017, and the original closing date was March 30, 2018.
What is the overall public health purpose of this FOA?
The FOA targets a clear public health need: better, faster, and less burdensome diagnosis of endometriosis, adenomyosis, and uterine fibroids, with small businesses positioned to translate new diagnostic ideas into usable products.
Browse more opportunities from the same category: Health, Income Security and Social Services
Next opportunity: Lab to Marketplace: Tools for Brain and Behavioral Research (R43/R44 - Clinical Trial Optional
Previous opportunity: Notice of Intent
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 RFA HD 19 006
Applicants also applied for:
Applicants who have applied for this opportunity (RFA HD 19 006) also looked into and applied for these:
| Funding Opportunity |
|---|
| Drug Repurposing for Conditions Affecting Neonates and Pregnant Women (R01 - Clinical Trial Optional) Apply for PAR 18 506 Funding Number: PAR 18 506 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Discovery of Molecular Targets for Pregnancy-Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (R01 - Clinical Trial Optional) Apply for PAR 18 511 Funding Number: PAR 18 511 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Human-Animal Interaction (HAI) Research (R21 - Clinical Trial Optional) Apply for PAR 18 650 Funding Number: PAR 18 650 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $200,000 |
| Human-Animal Interaction (HAI) Research (R03 - Clinical Trial Optional) Apply for PAR 18 649 Funding Number: PAR 18 649 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $50,000 |
| Developmental Pharmacodynamics and Models of Drug Effects in Pediatrics (R03 Clinical Trial Optional) Apply for PA 18 687 Funding Number: PA 18 687 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $50,000 |
| Innovative Therapies and Tools for Screenable Disorders (R01 Clinical Trial Optional) Apply for PAR 18 689 Funding Number: PAR 18 689 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Innovative Therapies and Tools for Screenable Disorders (R03 Clinical Trial Optional) Apply for PAR 18 690 Funding Number: PAR 18 690 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $50,000 |
| Innovative Therapies and Tools for Screenable Disorders (R21 Clinical Trial Optional) Apply for PAR 18 691 Funding Number: PAR 18 691 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $200,000 |
| Developmental Pharmacodynamics and Models of Drug Effects in Pediatrics (R01 Clinical Trial Optional) Apply for PA 18 688 Funding Number: PA 18 688 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Reproductive Scientist Development Program (RSDP) (K12 Clinical Trial Not Allowed) Apply for RFA HD 18 103 Funding Number: RFA HD 18 103 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $920,000 |
| Small Research Grants for Establishing Basic Science-Clinical Collaborations to Understand Structural Birth Defects (R03 - Clinical Trial Not Allowed) Apply for PAR 18 734 Funding Number: PAR 18 734 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $75,000 |
| Small Research Grants for Analyses of Data for the Gabriella Miller Kids First Data Resource (R03 - Clinical Trial Not Allowed) Apply for PAR 18 733 Funding Number: PAR 18 733 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $200,000 |
| Identification and Management of Behavioral Symptoms and Mental Health Conditions in Individuals with Intellectual Disabilities (R01 - Clinical Trial Optional) Apply for PAR 18 766 Funding Number: PAR 18 766 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Patient Safety in the Context of Perinatal, Neonatal, and Pediatric Care (R01 - Clinical Trial Optional) Apply for PA 18 790 Funding Number: PA 18 790 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Patient Safety in the Context of Perinatal, Neonatal, and Pediatric Care (R03 - Clinical Trial Optional) Apply for PA 18 791 Funding Number: PA 18 791 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $50,000 |
| Rare Genetic Syndromes as a Window into the Genetic Architecture of Mental Disorders (Collaborative U01 Clinical Trial Not Allowed) Apply for RFA MH 19 201 Funding Number: RFA MH 19 201 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Rare Genetic Syndromes as a Window into the Genetic Architecture of Mental Disorders (U01 Clinical Trial Not Allowed) Apply for RFA MH 19 200 Funding Number: RFA MH 19 200 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Immune Mechanisms at the Maternal-Fetal Interface (R01 Clinical Trial Optional) Apply for RFA AI 18 023 Funding Number: RFA AI 18 023 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| The Role of Epitranscriptomics in Development and Disease (R21 - Clinical Trial Not Allowed) Apply for PAR 18 831 Funding Number: PAR 18 831 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $200,000 |
| Development of Novel Nonsteroidal Contraceptive Methods (R61/R33 - Clinical Trial Not Allowed) Apply for RFA HD 19 015 Funding Number: RFA HD 19 015 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $500,000 |
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 "RFA HD 19 006", 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.