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

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

What is this funding opportunity?

This is an NIH discretionary grant funding opportunity titled "The Development of Novel or Improved Infertility Technologies (R61/R33 Clinical Trial Optional)" under funding opportunity number RFA-HD-26-001. It supports development-focused projects intended to move infertility-related innovations from early concepts and feasibility work into more validated technologies that are positioned to progress toward clinical development.

What is the main goal of the program?

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). The program is oriented toward practical technology development rather than basic research alone.

What kinds of projects are a good fit?

Projects are expected to be development-focused and capable of credibly leading to improved outcomes in infertility evaluation or treatment, especially within ART workflows. Examples described include work that improves success rates, safety, embryo or gamete handling and assessment, implantation outcomes, treatment personalization, patient experience, and access or efficiency in infertility care delivery.

What types of technologies does the NOFO support?

The opportunity supports creating or substantially improving technologies such as drugs, medical devices, diagnostics, laboratory tools, products, and clinical practices that could be adopted in infertility care.

Is this opportunity meant for basic research?

No. While scientific rigor is still essential, this opportunity is described as being oriented toward practical, development-focused projects rather than supporting basic research alone.

What does the R61/R33 mechanism mean?

This opportunity uses the NIH phased innovation mechanism. In general terms, the R61 phase supports early-stage, milestone-driven work to de-risk the concept, demonstrate feasibility, and generate proof-of-concept data. If pre-specified milestones are met, the project can transition to the R33 phase for the next stage of development and validation.

What is the purpose of the R61 phase?

The R61 phase is intended for early-stage, milestone-driven efforts that reduce key risks, establish feasibility, and produce proof-of-concept results needed to justify continued development.

What is the purpose of the R33 phase?

The R33 phase supports further development and validation intended to position the technology for later clinical testing, broader implementation, regulatory steps, or other downstream pathways.

Does an R61 award automatically transition to R33?

No. Transition is tied to whether the project meets pre-specified milestones. The NOFO describes milestone achievement as the basis for moving from R61 to R33.

Are clinical trials required?

No. The opportunity is labeled "Clinical Trial Optional," meaning applicants may propose clinical trials if appropriate to the technology and its stage of development, but a clinical trial is not required.

Can a project be entirely preclinical?

Yes. The description indicates that strong applications can be either preclinical or clinical depending on readiness and the most sensible validation plan for the technology.

What is the program especially interested in improving within ART?

The NOFO emphasizes meaningful impact on ART and includes areas such as embryo or gamete handling and assessment, implantation outcomes, improving safety, and increasing success rates, as well as improving personalization, patient experience, and operational efficiency.

Does the NOFO encourage multidisciplinary teams?

Yes. Multidisciplinary approaches are explicitly encouraged. The description notes combinations of expertise may include reproductive medicine, embryology, pharmacology, bioengineering, computational methods, clinical operations, regulatory science, and implementation considerations, depending on what is being developed.

Who is eligible to apply?

Eligibility is broad and includes many public and private organizations. Examples listed include various levels of government (state, county, city/township, special districts), independent school districts, public and private institutions of higher education, federally recognized Native American tribal governments, tribal organizations, public housing authorities/Indian housing authorities, nonprofits (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.

Are non-U.S. organizations eligible?

Yes. The NOFO notes additional eligible applicant categories including non-U.S. (foreign) organizations, as well as regional organizations and U.S. territories or possessions.

Are federal government agencies eligible to apply?

Yes. The NOFO notes additional eligible applicant categories including eligible federal government agencies.

Are faith-based or community-based organizations eligible?

Yes. The NOFO includes faith-based or community-based organizations among additional eligible applicant categories.

What is the CFDA number and activity category listed?

The opportunity is listed under CFDA number 93.865 and is issued by NIH under the Health, Income Security and Social Services activity category.

When was the opportunity created and when is the closing date?

The opportunity was created on 2025-09-22, and the original application closing date is 2025-11-20.

Is the award ceiling or number of awards specified here?

No. The provided source information notes that fields such as the award ceiling and expected number of awards are not specified, and applicants would need to consult the full NOFO text for those details.

What other details might require checking the full NOFO?

Based on the information provided, applicants would need the full NOFO to confirm budget limits (if any), project period expectations, detailed milestone and transition requirements between phases, and any institute-specific priorities or review criteria.

What does a competitive application typically include?

The description indicates that a competitive application would typically (1) define a clear infertility-related problem, (2) explain why existing approaches are insufficient, (3) present a development plan that is realistic for the R61 stage and appropriately ambitious for the R33 stage, (4) include measurable go/no-go milestones, (5) describe validation strategies aligned with future clinical development needs, and (6) demonstrate a credible team and environment to advance the technology toward real-world use in infertility care and ART settings.

What kinds of outcomes is the program aiming to influence?

The program is aimed at technologies that can improve infertility evaluation or treatment outcomes, including ART success rates and safety, as well as factors like patient experience, access, and efficiency in care delivery.

Does the program support technologies intended for real-world adoption?

Yes. The NOFO emphasizes technologies and practices that could be adopted in infertility care, and it highlights development and validation work that positions the technology for downstream clinical development, implementation, or regulatory steps.