Development of Novel or Improved Infertility Technologies (R61/R33 Clinical Trial Optional) | RFA HD 26 001

Opportunity Information: Apply for RFA HD 26 001

The Development of Novel or Improved Infertility Technologies (R61/R33 Clinical Trial Optional) funding opportunity (RFA-HD-26-001) is a National Institutes of Health (NIH) discretionary grant program focused on moving infertility-related innovations from early concept and feasibility work into more mature, validated technologies that are ready to progress toward clinical development. The overall aim is to improve fertility outcomes for people experiencing infertility, with a strong emphasis on advances that can meaningfully impact Assisted Reproductive Technologies (ART). Rather than supporting basic research alone, this opportunity is oriented toward practical, development-focused projects that use multidisciplinary teams to create or substantially improve technologies such as drugs, medical devices, diagnostics, laboratory tools, products, and clinical practices that could be adopted in infertility care.

A key feature of this NOFO is the use of the R61/R33 phased innovation mechanism. In general terms, the R61 phase supports early-stage, milestone-driven work that de-risks the concept, demonstrates feasibility, and generates proof-of-concept data. If the project meets pre-specified milestones, it can transition to the R33 phase, which supports the next stage of development and validation needed to position the technology for later clinical testing, broader implementation, regulatory steps, or other downstream pathways. The “Clinical Trial Optional” designation signals that applicants may propose clinical trials if appropriate to the technology and stage of development, but they are not required to do so; strong applications can be either preclinical or clinical depending on readiness and the most sensible validation plan.

The types of research envisioned are those that can credibly lead to improved outcomes in infertility evaluation or treatment, especially within ART workflows. This can include innovations that improve success rates, safety, embryo or gamete handling and assessment, implantation outcomes, treatment personalization, patient experience, or access and efficiency in care delivery. The NOFO explicitly encourages multidisciplinary approaches, which often means combining expertise across reproductive medicine, embryology, pharmacology, bioengineering, computational methods, clinical operations, regulatory science, and implementation considerations, depending on what is being developed.

Eligibility is broad and includes a wide range of public and private organizations. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other entities. The NOFO also notes additional eligible applicant categories, including eligible federal government agencies, faith-based or community-based organizations, Indian/Native American tribal governments other than federally recognized, non-U.S. (foreign) organizations, regional organizations, and U.S. territories or possessions. This breadth is consistent with a technology-development program that may involve academic labs, clinics, startups, established companies, health systems, community partners, and international collaborators.

Administratively, this opportunity is issued by NIH under the Health, Income Security and Social Services activity category, with CFDA number 93.865. The opportunity was created on 2025-09-22, and the original application closing date is 2025-11-20. Some fields such as the award ceiling and expected number of awards are not specified in the provided source data, so applicants would need to consult the full NOFO text for budget limits (if any), project period expectations, milestone and transition requirements between phases, and any institute-specific priorities or review criteria.

In practical terms, a competitive application under this NOFO would typically describe a clearly defined infertility-related problem, explain why existing approaches are insufficient, and lay out a development plan that is realistic for the R61 stage and appropriately ambitious for the R33 stage. It would also usually include measurable go/no-go milestones, validation strategies aligned with future clinical development needs, and a credible team and environment capable of productively advancing the technology toward real-world use in infertility care and ART settings.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Development of Novel or Improved Infertility Technologies (R61/R33 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 2025-09-22.
• Applicants must submit their applications by 2025-11-20. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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