Opportunity Information: Apply for RFA HD 20 010
The National Institutes of Health (NIH) funding opportunity titled "Technologies to Advance Precision Medicine Diagnosis and Treatment of Infertility, Reproductive Tract and Gynecologic Disorders Affecting Fertility (R43/R44 Clinical Trial Optional)" (Funding Opportunity Number: RFA-HD-20-010; CFDA: 93.865) is a discretionary grant program aimed specifically at small businesses. It uses the NIH SBIR/STTR-style mechanism under the R43/R44 activity codes, which generally support early-stage feasibility work (Phase I, typically R43) and then further development and commercialization-focused work (Phase II, typically R44). The notice also states "Clinical Trial Optional," meaning applicants may propose projects that include a clinical trial if it is appropriate for the technology and stage of development, but a clinical trial is not required.
At its core, the opportunity is designed to push precision medicine forward in reproductive health by translating modern biological discovery tools into practical clinical solutions. NIH is encouraging small businesses to work hand-in-hand with scientists and clinicians across female and male reproductive health, infertility, andrology, and gynecology. The main idea is to take discoveries coming out of omics and biomarker research and turn them into usable products that can meaningfully improve diagnosis and care. The FOA highlights omics areas such as genomics, epigenomics, and metabolomics, along with the broader identification and validation of disease biomarkers. In practical terms, the NIH is looking for proposals that move beyond basic research and toward technologies that can increase diagnostic specificity, help stratify patients, guide treatment decisions, and ultimately improve clinical outcomes for people affected by infertility or fertility-impairing reproductive tract and gynecologic disorders.
The kinds of deliverables this FOA is aiming to stimulate include new devices, laboratory or point-of-care assays, digital applications, and other enabling technologies that bring precision medicine into routine reproductive healthcare. That could involve tools that detect clinically meaningful molecular signatures, platforms that integrate multiple biomarker types, or software-based solutions that translate complex omics data into actionable clinical guidance. The emphasis on improving "specificity of diagnosis and clinical care" signals interest in reducing ambiguity in reproductive health workups, distinguishing among conditions with overlapping symptoms, identifying underlying biological causes more accurately, and supporting better targeted interventions rather than one-size-fits-all approaches.
Eligibility is restricted to small businesses, consistent with the SBIR/STTR intent of stimulating innovation and commercialization through the small business sector. Foreign eligibility is explicitly limited: non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. However, the FOA notes that "foreign components" as defined in the NIH Grants Policy Statement may be allowed, which typically means a U.S. applicant might be able to include certain well-justified foreign activities or collaborations in a limited way, provided they meet NIH policy requirements and are essential to the project.
Administratively, the opportunity was created on 2019-08-07 and had an original closing date of 2019-12-03. The sponsoring agency is the NIH, and the activity category listed is "Health, Income Security and Social Services," reflecting the public health and clinical care focus. While the provided listing does not specify an award ceiling or expected number of awards, the overall structure and intent make clear that NIH is seeking multiple small business-led projects that can translate cutting-edge reproductive biology and biomarker science into tangible, clinically relevant diagnostic or treatment-guiding technologies.Apply for RFA HD 20 010
- The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Technologies to Advance Precision Medicine Diagnosis and Treatment of Infertility, Reproductive Tract and Gynecologic Disorders Affecting Fertility (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 2019-08-07.
- Applicants must submit their applications by 2019-12-03. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
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Frequently Asked Questions (FAQs)
What is the title of this NIH funding opportunity?
The funding opportunity is titled "Technologies to Advance Precision Medicine Diagnosis and Treatment of Infertility, Reproductive Tract and Gynecologic Disorders Affecting Fertility (R43/R44 Clinical Trial Optional)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-HD-20-010.
What CFDA number is associated with this opportunity?
The CFDA number listed is 93.865.
Which agency is sponsoring this grant opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What type of grant mechanism is being used (R43/R44)?
This opportunity uses NIH SBIR/STTR-style activity codes R43 and R44, which generally align with a phased approach: Phase I feasibility work (typically R43) followed by Phase II development and commercialization-focused work (typically R44).
Who is eligible to apply?
Eligibility is restricted to small businesses, consistent with the SBIR/STTR intent to stimulate innovation and commercialization through the small business sector.
Are non-U.S. (foreign) organizations eligible to apply?
No. Non-domestic (non-U.S.) entities are explicitly not eligible to apply.
Can a U.S. small business include work performed outside the United States?
Non-domestic components of U.S. organizations are not eligible. However, the FOA notes that "foreign components" (as defined in the NIH Grants Policy Statement) may be allowed in limited circumstances when well-justified, essential to the project, and compliant with NIH policy.
What does "Clinical Trial Optional" mean in this FOA?
"Clinical Trial Optional" means applicants may propose a project that includes a clinical trial if a clinical trial is appropriate for the technology and stage of development, but a clinical trial is not required to apply.
What is the main goal of this funding opportunity?
The FOA is designed to advance precision medicine in reproductive health by translating modern biological discovery tools into practical clinical solutions that improve diagnosis and care for infertility and fertility-impairing reproductive tract and gynecologic disorders.
What scientific and clinical areas does this opportunity focus on?
The focus includes female and male reproductive health, infertility, andrology, and gynecology, with an emphasis on turning omics and biomarker discoveries into clinically usable technologies.
What types of research or discovery approaches are highlighted?
The FOA highlights omics and biomarker approaches including genomics, epigenomics, and metabolomics, along with broader efforts to identify and validate disease biomarkers.
What kinds of projects is NIH encouraging under this FOA?
NIH is encouraging projects that move beyond basic research toward technologies that can improve diagnostic specificity, stratify patients, guide treatment decisions, and improve clinical outcomes for people affected by infertility or related disorders affecting fertility.
What kinds of deliverables are expected or encouraged?
Examples of deliverables include new devices, laboratory or point-of-care assays, digital applications, and other enabling technologies that bring precision medicine capabilities into routine reproductive healthcare.
Are software or digital health tools within scope?
Yes. The FOA explicitly mentions digital applications and software-based solutions that can translate complex omics data into actionable clinical guidance.
Is the FOA focused on diagnostics only, or also treatment guidance?
It targets both diagnosis and treatment guidance, with an emphasis on technologies that improve specificity of diagnosis, support patient stratification, and guide treatment decisions.
What does the FOA mean by improving "specificity of diagnosis and clinical care"?
The emphasis is on reducing ambiguity in reproductive health evaluations, distinguishing among conditions with overlapping symptoms, identifying underlying biological causes more accurately, and enabling more targeted interventions rather than one-size-fits-all care.
Does this FOA require collaboration with clinicians or scientists?
The FOA encourages small businesses to work hand-in-hand with scientists and clinicians across relevant reproductive health fields to translate biomarker and omics discoveries into usable clinical products.
When was this opportunity created?
The opportunity was created on 2019-08-07.
What was the original closing date?
The original closing date listed is 2019-12-03.
What activity category is associated with this opportunity?
The activity category listed is "Health, Income Security and Social Services," reflecting the public health and clinical care focus of the program.
Does the provided listing include an award ceiling or number of expected awards?
No. The provided information does not specify an award ceiling or the expected number of awards.
What is the overall intent behind using the SBIR/STTR-style small business mechanism here?
The structure and intent indicate NIH is seeking small business-led projects that can translate cutting-edge reproductive biology and biomarker science into tangible, clinically relevant technologies, with an eye toward development and commercialization.
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