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.

  • 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.
Apply for RFA HD 20 010

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