Opportunity Information: Apply for RFA HD 09 025
Apply for RFA HD 09 025
- The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Noninvasive Assays of Human Oocytes and Preimplantation Embryos (SBIR R43)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on May 1, 2009 and posted on May 1, 2009.
- Applicants must submit their applications by Nov 10, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $300,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $100,000.00 in funding.
- Eligible applicants include: Small businesses.
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Opportunity Summary:
The grant opportunity titled "Noninvasive Assays of Human Oocytes and Preimplantation Embryos (SBIR R43)" is a National Institutes of Health (NIH) funding announcement aimed at small business concerns that can develop practical, high-resolution, noninvasive ways to assess the quality of individual human oocytes (eggs) and preimplantation embryos produced in in vitro fertilization (IVF) laboratories. The central scientific and clinical problem the program is trying to solve is that IVF labs often must choose which embryo(s) to transfer using imperfect indicators of viability, and uncertainty tends to push clinics toward transferring multiple embryos to improve pregnancy odds. That practice increases the likelihood of multiple pregnancies, which carry higher health risks for both the pregnant patient and the offspring and drive up medical costs. By supporting better, noninvasive tools that can more accurately predict developmental potential, the FOA is designed to make single embryo transfer a more confident and more common decision in assisted reproduction.
The solicitation specifically emphasizes assays that work at the level of a single oocyte or a single embryo and do not harm or materially disturb the sample, since embryos and oocytes are scarce, valuable, and time-sensitive in the IVF workflow. The envisioned technologies should deliver high-resolution information while remaining feasible for routine clinical lab use. The FOA highlights several practical design requirements: the assay should be rapid (compatible with tight clinical timelines for embryo selection), inexpensive (so clinics can adopt it without prohibitive cost), and based on simple laboratory manipulations (minimizing specialized handling, complicated steps, or highly technical operator dependence). At the same time, it must achieve a high level of accuracy, meaning it should meaningfully improve the ability to predict which oocyte or embryo is most likely to develop successfully. In effect, NIH is signaling that the best proposals will bridge both innovation and deployability, not just proof-of-concept science.
This is an SBIR Phase I opportunity using the R43 mechanism, which is typically intended to support early-stage feasibility and prototype development within a small business. The FOA runs in parallel with a companion announcement of identical scientific scope under the STTR mechanism (R41/R42), which is generally used when the project formally involves a research institution partner with a significant role. Applicants choosing the SBIR track would be proposing a small business-led effort to demonstrate feasibility and establish the technical foundation for later-stage development, validation, and commercialization work.
From an administrative standpoint, the opportunity is listed as discretionary funding in the health and related social services domain and falls under CFDA 93.865 (Child Health and Human Development Extramural Research), indicating alignment with the NICHD mission space within NIH. The eligible applicants are small businesses only, and there is no cost sharing or matching requirement. The FOA was posted May 1, 2009, with an application closing date of November 10, 2009, and an archive date of December 11, 2009. The estimated total funding is $300,000, with an award ceiling of $100,000, consistent with a Phase I SBIR budget scale meant to support initial technical milestones rather than large clinical trials.
Overall, this funding opportunity is best understood as a targeted push to modernize embryo and oocyte selection by funding small businesses to create noninvasive, accurate, and clinic-friendly assays. The broader public health payoff NIH is aiming for is fewer multiple gestations through increased single embryo transfer, leading to safer pregnancies, better neonatal outcomes, and lower downstream healthcare expenditures. For applicants, the strongest fit would be projects that can credibly demonstrate both scientific sensitivity (detecting meaningful markers of developmental competence) and operational compatibility with real IVF lab constraints, including speed, simplicity, and cost.
Frequently Asked Questions (FAQ)
What is the title of this grant opportunity?
The funding announcement is titled "Noninvasive Assays of Human Oocytes and Preimplantation Embryos (SBIR R43)."
Which federal agency is offering this funding opportunity?
This is a National Institutes of Health (NIH) funding announcement.
What is the main goal of the program?
The program aims to support the development of practical, high-resolution, noninvasive assays that can assess the quality of individual human oocytes (eggs) and preimplantation embryos produced in in vitro fertilization (IVF) laboratories.
What problem in IVF is the FOA trying to address?
IVF laboratories often must decide which embryo(s) to transfer using imperfect indicators of embryo viability. Because selection is uncertain, clinics may transfer multiple embryos to improve pregnancy odds, which increases the likelihood of multiple pregnancies. Multiple pregnancies carry higher health risks for the pregnant patient and offspring and increase medical costs.
How would better embryo and oocyte assessment tools change clinical practice?
By improving noninvasive prediction of developmental potential, the FOA is designed to make single embryo transfer a more confident and more common decision in assisted reproduction.
What types of technologies or assays does NIH want to fund?
NIH is looking for noninvasive, high-resolution assays that assess quality at the level of a single oocyte or a single embryo and are feasible for routine clinical use in IVF labs.
Does the assay need to work on individual samples, or can it be a batch test?
The solicitation emphasizes assays that work at the level of a single oocyte or a single embryo.
Are invasive or destructive methods allowed?
The FOA emphasizes noninvasive approaches that do not harm or materially disturb the oocyte or embryo, since these samples are scarce, valuable, and time-sensitive in the IVF workflow.
What does "high-resolution" mean in the context of this opportunity?
Based on the description provided, "high-resolution" refers to assays that deliver detailed, informative measurements suitable for improving embryo or oocyte selection decisions, while still being compatible with clinical lab routines.
What practical design requirements are highlighted?
The FOA highlights several practical requirements: the assay should be rapid (fit within tight clinical timelines), inexpensive (practical for clinics to adopt), and based on simple laboratory manipulations (minimizing specialized handling or highly technical operator dependence), while still achieving high accuracy.
Why is speed important for the assay?
Speed is important because embryo selection in IVF occurs under tight clinical timelines, and the assay must be compatible with those decision windows.
Why is cost a major consideration?
The FOA stresses that the assay should be inexpensive so that clinics can adopt it without prohibitive cost barriers.
How important is ease of use in an IVF lab setting?
Ease of use is a core emphasis. NIH signals that the assay should rely on simple laboratory manipulations and avoid complicated steps or approaches that require highly specialized operators, supporting routine clinical deployment.
What does NIH mean by "accuracy" in this FOA?
In context, accuracy means the assay should meaningfully improve the ability to predict which oocyte or embryo is most likely to develop successfully, beyond imperfect current indicators.
Is this opportunity focused on research only, or also on deployment in clinics?
It is positioned as both innovation and deployability. The FOA emphasizes bridging new technical capability with operational compatibility in real IVF lab constraints (speed, simplicity, and cost), not just proof-of-concept science.
What funding mechanism is used?
This is an SBIR Phase I opportunity using the R43 mechanism.
What stage of development is SBIR Phase I (R43) intended to support?
R43 Phase I is typically intended to support early-stage feasibility and prototype development within a small business, establishing the technical foundation for later development, validation, and commercialization work.
Is there a related STTR opportunity?
Yes. The FOA runs in parallel with a companion announcement of identical scientific scope under the STTR mechanism (R41/R42).
What is the difference between the SBIR track and the companion STTR track (as described here)?
As described, the SBIR track would be a small business-led effort to demonstrate feasibility, while the STTR mechanism (R41/R42) is generally used when the project formally involves a research institution partner with a significant role.
Who is eligible to apply?
Eligible applicants are small businesses only (small business concerns).
Is cost sharing or matching required?
No. There is no cost sharing or matching requirement stated for this opportunity.
What is the program area or domain for this funding?
The opportunity is listed as discretionary funding in the health and related social services domain.
What CFDA number is associated with this FOA, and what does it indicate?
The opportunity falls under CFDA 93.865 (Child Health and Human Development Extramural Research), indicating alignment with the NICHD mission space within NIH.
When was the FOA posted?
The FOA was posted on May 1, 2009.
What was the application closing date?
The application closing date was November 10, 2009.
When was the FOA archived?
The archive date was December 11, 2009.
How much total funding is estimated for this opportunity?
The estimated total funding is $300,000.
What is the award ceiling for an individual award?
The award ceiling is $100,000, consistent with a Phase I SBIR budget scale focused on initial technical milestones rather than large clinical trials.
What broader public health impact is NIH aiming for?
The FOA frames a public health payoff of fewer multiple gestations through increased single embryo transfer, leading to safer pregnancies, better neonatal outcomes, and lower downstream healthcare expenditures.
What kinds of projects are likely the best fit, based on the description?
Projects that can credibly demonstrate scientific sensitivity (detecting meaningful markers of developmental competence) while also fitting real IVF lab constraints (noninvasive handling, speed, simplicity, and low cost) appear most aligned with the stated goals.
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