Opportunity Information: Apply for RFA HD 09 017
Apply for RFA HD 09 017
- The National Institutes of Health in the education food and nutrition health income security and social services sector is offering a public funding opportunity titled "Safe and Effective Instruments and Devices for use in the Neonatal Intensive Care Units (SBIR R43)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173 Research Related to Deafness and Communication Disorders 93.389 National Center for Research Resources 93.838 Lung Diseases Research 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on May 29, 2009 and posted on May 29, 2009.
- Applicants must submit their applications by Jul 31, 2009. (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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Opportunity Summary:
The NIH funding opportunity RFA-HD-09-017, titled "Safe and Effective Instruments and Devices for use in the Neonatal Intensive Care Units (SBIR R43)," is a discretionary federal grant program aimed at small business concerns that want to do early-stage R and D on medical technologies for newborns and young children in neonatal intensive care settings. The central goal is to support research that creates entirely new instruments and devices, or meaningfully improves existing ones, so that monitoring and treatment in the NICU can be done more safely and more effectively for these especially vulnerable patients. In practical terms, the FOA is focused on technology development work that addresses the unique clinical and safety challenges of caring for neonates and small children, where factors like size, fragility, physiology, and infection risk can make standard devices designed for adults unsuitable or risky.
This announcement uses the SBIR Phase I grant mechanism (R43). That means it is specifically intended to fund feasibility-stage projects where a small business can demonstrate scientific and technical merit, show that an approach is workable, and generate the kind of early evidence needed to justify more advanced development later. The FOA runs in parallel with a separate but scientifically identical NIH announcement, RFA-HD-09-018, which uses the STTR mechanism (R41). In other words, applicants have two closely related pathways depending on whether they are pursuing an SBIR structure or an STTR structure, but the underlying technical scope is the same. A key limitation is that this FOA does not support SBIR Phase II, Fast Track, or Phase II Competing Renewal applications, so it is strictly aimed at Phase I proposals rather than later-stage commercialization or scale-up within this specific announcement.
Funding is provided by multiple NIH components, reflecting the cross-cutting nature of NICU device needs across child health, lungs, hearing and communication, diabetes/digestive/kidney conditions, and research resources. For fiscal year 2010, the set-aside amounts and expected awards are described as follows: NICHD plans to commit up to 900,000 in total costs to support up to 4 meritorious awards; NHLBI plans up to 450,000 in total costs for up to 2 awards; NIDCD plans up to 225,000 for up to 1 award; NIDDK plans up to 225,000 for up to 1 award; and NCRR plans up to 225,000 for up to 1 award. All awards are contingent on available appropriations and on NIH receiving a sufficient number of high-quality, meritorious applications. Future-year funding levels are not guaranteed and depend on annual congressional appropriations.
Eligibility is limited to small businesses, and there is no cost sharing or matching requirement, which is typical for SBIR opportunities and can be important for early-stage firms that may not have large reserves of non-federal capital. The opportunity is categorized under several CFDA programs, including Child Health and Human Development Extramural Research (93.865), Lung Diseases Research (93.838), Research Related to Deafness and Communication Disorders (93.173), Diabetes, Digestive, and Kidney Diseases Extramural Research (93.847), and National Center for Research Resources (93.389). The FOA was posted and created on May 29, 2009, with an original and current closing date of July 31, 2009, and an archive date of August 31, 2009, indicating it was a time-limited solicitation rather than an always-open program announcement.
Overall, this FOA is best understood as a targeted NIH SBIR Phase I solicitation intended to move NICU-focused device concepts from an idea or early prototype stage into demonstrated feasibility, with an emphasis on improving safety and effectiveness for newborn and pediatric patients. It offers multiple potential funding paths within NIH depending on the disease area or institute interest, but it is not itself a mechanism for Phase II follow-on within the same announcement. For applicants, the main task would be to propose a clear Phase I technical plan that addresses a real NICU need, shows how the device or instrument will be made safer and more effective for neonates or small children, and lays out measurable feasibility milestones that can be achieved within a Phase I scope.
Frequently Asked Questions (FAQs)
What is the funding opportunity RFA-HD-09-017?
RFA-HD-09-017 is an NIH funding opportunity titled "Safe and Effective Instruments and Devices for use in the Neonatal Intensive Care Units (SBIR R43)." It is a discretionary federal grant program intended to support small businesses performing early-stage research and development (R&D) on medical instruments and devices for neonatal intensive care unit (NICU) settings.
What is the main goal of this FOA?
The central goal is to support research that creates entirely new instruments and devices, or meaningfully improves existing ones, so NICU monitoring and treatment can be conducted more safely and more effectively for newborns and small children. The focus is on addressing NICU-specific clinical and safety challenges where standard adult-oriented devices may be unsuitable or risky.
What type of projects does this opportunity support?
This FOA supports feasibility-stage technology development projects. It is intended for early work that demonstrates scientific and technical merit, shows an approach is workable, and generates early evidence that could justify more advanced development later.
What grant mechanism is used under RFA-HD-09-017?
This announcement uses the SBIR Phase I grant mechanism (R43). That means it is specifically aimed at Phase I feasibility proposals rather than later-stage development or commercialization activities within the same announcement.
Does this FOA fund SBIR Phase II, Fast Track, or Phase II Competing Renewals?
No. A key limitation is that this FOA does not support SBIR Phase II, Fast Track, or Phase II Competing Renewal applications. It is strictly intended for SBIR Phase I proposals under the R43 mechanism.
Is there a related NIH opportunity for STTR applicants?
Yes. This FOA runs in parallel with a separate but scientifically identical NIH announcement, RFA-HD-09-018, which uses the STTR mechanism (R41). The technical scope is the same, but the mechanism differs depending on whether you pursue SBIR (R43) or STTR (R41).
Who is eligible to apply?
Eligibility is limited to small businesses (small business concerns). The FOA is presented as an SBIR opportunity and is intended for applicants that fit the small business eligibility framework.
Is cost sharing or matching required?
No. The FOA specifies that there is no cost sharing or matching requirement, which is typical for SBIR opportunities and can be important for early-stage firms without significant non-federal capital.
What patient populations and settings are emphasized?
The emphasis is on newborns and young children cared for in NICU settings. The FOA highlights challenges tied to patient size, fragility, physiology, and infection risk, which can make devices designed for adults inappropriate or unsafe in neonatal and pediatric contexts.
What kinds of improvements or innovations are being sought?
The FOA is focused on technology development that either (1) creates entirely new instruments and devices for NICU use, or (2) meaningfully improves existing devices so they are safer and more effective for neonatal and pediatric patients.
Which NIH components are involved in funding this FOA?
Funding is provided by multiple NIH components, reflecting cross-cutting NICU needs across different clinical and research areas. The FOA mentions the following participating NIH components: NICHD, NHLBI, NIDCD, NIDDK, and NCRR.
What were the FY2010 planned funding amounts and number of expected awards?
For fiscal year 2010, the FOA describes the following set-aside amounts and expected awards (all in total costs):
- NICHD: up to $900,000 to support up to 4 meritorious awards
- NHLBI: up to $450,000 to support up to 2 awards
- NIDCD: up to $225,000 to support up to 1 award
- NIDDK: up to $225,000 to support up to 1 award
- NCRR: up to $225,000 to support up to 1 award
Are awards guaranteed at those levels?
No. The FOA states that all awards are contingent on available appropriations and on NIH receiving a sufficient number of high-quality, meritorious applications. It also notes that future-year funding levels are not guaranteed and depend on annual congressional appropriations.
What are the CFDA program numbers associated with this opportunity?
The FOA is categorized under several CFDA programs, including:
- 93.865 - Child Health and Human Development Extramural Research
- 93.838 - Lung Diseases Research
- 93.173 - Research Related to Deafness and Communication Disorders
- 93.847 - Diabetes, Digestive, and Kidney Diseases Extramural Research
- 93.389 - National Center for Research Resources
When was this FOA posted and what were the key dates?
The FOA was posted and created on May 29, 2009. The original and current closing date was July 31, 2009. The archive date was August 31, 2009. These dates indicate it was a time-limited solicitation rather than an always-open program announcement.
What does it mean that this is a time-limited solicitation?
Based on the provided dates (a specific closing date and an archive date), the FOA appears to have been open for a defined period and then archived, rather than remaining continuously open for submissions.
What should an applicant focus on when proposing a Phase I project under this FOA?
The FOA indicates the main task is to propose a clear Phase I technical plan that addresses a real NICU need, explains how the instrument or device will be made safer and more effective for neonates or small children, and includes measurable feasibility milestones that can be achieved within a Phase I scope.
Does the FOA specify whether this is for commercialization or scale-up?
The FOA is described as focused on feasibility-stage R&D rather than later-stage commercialization or scale-up within this specific announcement, especially since it does not support Phase II or Fast Track under this FOA.
Why does the FOA emphasize neonate- and pediatric-specific device design?
The FOA explains that neonates and small children have unique clinical and safety challenges in the NICU, including issues related to size, fragility, physiology, and infection risk. These factors can make standard adult devices unsuitable or risky, which is why the FOA prioritizes NICU-appropriate designs or improvements.
How should applicants choose between the SBIR and STTR pathways mentioned?
The FOA notes that there are two closely related pathways with the same scientific scope: SBIR under RFA-HD-09-017 (R43) and STTR under RFA-HD-09-018 (R41). The choice depends on whether the applicant is pursuing an SBIR structure or an STTR structure.
What is the overall intent of RFA-HD-09-017 in the NIH portfolio?
Overall, it is a targeted NIH SBIR Phase I solicitation intended to move NICU-focused device concepts from an idea or early prototype stage into demonstrated feasibility, with a strong emphasis on improving safety and effectiveness for newborn and pediatric patients.
Browse more opportunities from the same category: Education Food and Nutrition Health Income Security and Social Services
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