Opportunity Information: Apply for RFA HD 12 192
Apply for RFA HD 12 192
- The National Institutes of Health in the 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): 93.839 Blood Diseases and Resources Research 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Jun 14, 2011 and posted on Jun 14, 2011.
- Applicants must submit their applications by Sep 19, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $250,000.00 in funding.
- The number of recipients for this funding is limited to 4 candidate(s).
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria 1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor 2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture 3. Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or it must be a for profit business concern that is at least 51 percent owned and controlled by another for profit business concern that is at least 51 owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States and 4. Has, including its affiliates, not more than 500 employees. SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other or (b) a third party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R and R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.
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Opportunity Summary:
The funding opportunity titled "Safe and Effective Instruments and Devices for Use in the Neonatal Intensive Care Units (SBIR) (R43)" is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) Phase I grant solicitation led by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in partnership with the National Heart, Lung, and Blood Institute (NHLBI). Its central purpose is to stimulate early-stage, high-impact research and development by US-based small businesses aimed at creating new medical devices and instruments, or meaningfully improving existing ones, specifically for the safe and effective monitoring and treatment of newborn infants and young children in neonatal intensive care unit (NICU) settings. The emphasis is on practical innovations that reduce risk, increase reliability, and improve clinical care for very small and medically fragile patients, where standard devices designed for older children or adults often do not perform well or may introduce avoidable safety concerns.
This announcement (Funding Opportunity Number RFA-HD-12-192) falls under a discretionary grant mechanism and uses the SBIR R43 activity code, which corresponds to Phase I feasibility and proof-of-concept work. In Phase I terms, applicants are generally expected to show that the scientific and technical approach is sound, that the concept is feasible, and that there is a credible path toward a development-ready prototype or next-stage validation. In the NICU context, that can include device designs that better fit neonatal anatomy and physiology, sensors that deliver accurate readings despite tiny size or motion artifacts, tools that minimize blood loss or skin injury, and instruments that can operate safely in the complex environment of incubators, ventilators, and fragile clinical workflows. While the detailed scientific scope is typically spelled out in the full announcement, the summary makes clear that the NIH is looking for technology development that directly supports monitoring and treatment and that prioritizes neonatal safety and efficacy.
The expected scale of the program is modest and competitive. NIH estimated total funding for this opportunity at $1,000,000, with an expectation of about four awards. The listed award ceiling is $250,000, which aligns with typical SBIR Phase I budget levels, signaling that applications should be tightly focused on clear milestones achievable within a Phase I project period. There is no cost sharing or matching requirement, meaning the applicant is not required to contribute non-federal funds as a condition of the award, though SBIR applicants commonly leverage outside resources or partnerships to strengthen the development plan.
Eligibility is limited to US small business concerns, and the announcement provides a detailed definition consistent with SBIR rules and Small Business Administration regulations. To qualify, the business must be organized for profit, have a place of business in the United States, and operate primarily in the United States or otherwise make a significant contribution to the US economy (for example through taxes or use of American labor and materials). It must be an eligible legal entity type such as a sole proprietorship, partnership, LLC, corporation, joint venture, association, trust, or cooperative, with special limits for joint ventures including restrictions on foreign participation. Ownership and control must be at least 51 percent by one or more US citizens or permanent resident aliens (or by another qualifying for-profit company that itself meets the same ownership and control standards). In addition, the company, including affiliates, must have no more than 500 employees. The notice also highlights that affiliation rules apply, meaning entities can be considered affiliates when one controls another or when a third party controls both, which can affect employee counts and eligibility. Applicants are directed to rely on the SF424 (R&R) SBIR/STTR Application Guide for the full eligibility and application requirements.
From an administrative standpoint, the opportunity was posted and created on June 14, 2011, with an original and current closing date of September 19, 2011, and an archive date of October 20, 2011. That means this specific solicitation is no longer open, but it remains a useful reference for understanding NIH priorities in neonatal device development and for anticipating similar SBIR topics that may appear in later years. The program is categorized under Health, Income Security, and Social Services, and it lists two CFDA numbers: 93.839 (Blood Diseases and Resources Research) and 93.865 (Child Health and Human Development Extramural Research), reflecting the involvement and mission overlap of NICHD and NHLBI, particularly where neonatal monitoring and treatment intersect with cardiopulmonary function, blood oxygenation, and related intensive care needs.
For applicants or readers seeking the full requirements, the announcement provided an NIH grants guide link to the official posting, and it included contact guidance for technical issues accessing the announcement through the NIH Office of Extramural Research (OER) webmaster. In practical terms, the key takeaway is that NIH, through NICHD and NHLBI, used this SBIR Phase I opportunity to encourage small businesses to tackle real-world NICU technology gaps by building safer, more effective neonatal-appropriate instruments and devices, with funding sized to support early feasibility work that could lead to later-stage development and commercialization.
Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The opportunity is titled "Safe and Effective Instruments and Devices for Use in the Neonatal Intensive Care Units (SBIR) (R43)."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-HD-12-192.
Which federal agency is offering this opportunity?
This is a National Institutes of Health (NIH) funding opportunity.
Which NIH Institutes are involved?
The solicitation is led by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in partnership with the National Heart, Lung, and Blood Institute (NHLBI).
What kind of grant mechanism is this?
It is a discretionary grant mechanism under the NIH Small Business Innovation Research (SBIR) program.
What does the activity code R43 mean?
R43 corresponds to SBIR Phase I, which focuses on feasibility and proof-of-concept work.
What is the main purpose of this solicitation?
The purpose is to stimulate early-stage, high-impact research and development by US-based small businesses to create new medical devices and instruments, or meaningfully improve existing ones, for safe and effective monitoring and treatment of newborn infants and young children in neonatal intensive care unit (NICU) settings.
What patient population is the technology intended for?
The technologies are intended for newborn infants and young children receiving care in NICU settings, particularly very small and medically fragile patients.
What types of projects are responsive to this opportunity?
Projects that develop or significantly improve devices and instruments used for monitoring and treatment in the NICU, with a strong emphasis on neonatal safety, clinical effectiveness, reliability, and practical use within NICU workflows.
Why is there a special focus on NICU-specific devices?
The opportunity highlights that standard devices designed for older children or adults often do not perform well in NICU settings or may introduce avoidable safety concerns for neonates.
What are examples of the kinds of improvements the NIH is looking for?
Examples mentioned include device designs that better fit neonatal anatomy and physiology, sensors that provide accurate readings despite tiny size or motion artifacts, tools that minimize blood loss or skin injury, and instruments that can operate safely around incubators, ventilators, and fragile clinical workflows.
Is the goal basic research or practical technology development?
The emphasis is on practical innovations and technology development that directly supports monitoring and treatment in the NICU and prioritizes neonatal safety and efficacy.
What is generally expected in an SBIR Phase I (R43) project?
Phase I projects are generally expected to demonstrate that the scientific and technical approach is sound, that the concept is feasible, and that there is a credible path toward a development-ready prototype or next-stage validation.
How much total funding did NIH estimate for this opportunity?
NIH estimated total funding at $1,000,000 for this opportunity.
How many awards were expected?
The estimate was about four awards.
What is the maximum award amount (award ceiling)?
The listed award ceiling is $250,000, which aligns with typical SBIR Phase I budget levels.
Does this opportunity require cost sharing or matching funds?
No. The solicitation states there is no cost sharing or matching requirement.
Who is eligible to apply?
Eligibility is limited to US small business concerns that meet SBIR and Small Business Administration requirements referenced in the announcement.
What basic organizational characteristics must an eligible business have?
The business must be organized for profit, have a place of business in the United States, and operate primarily in the United States or otherwise make a significant contribution to the US economy (for example through taxes or use of American labor and materials).
What legal entity types are eligible?
Eligible entity types mentioned include a sole proprietorship, partnership, LLC, corporation, joint venture, association, trust, or cooperative, subject to SBIR rules.
Are there ownership and control requirements?
Yes. Ownership and control must be at least 51 percent by one or more US citizens or permanent resident aliens, or by another qualifying for-profit company that itself meets the same ownership and control standards.
Is there a company size limit?
Yes. The company, including affiliates, must have no more than 500 employees.
What are "affiliation" rules and why do they matter?
The announcement notes that affiliation rules apply, meaning entities can be considered affiliates when one controls another or when a third party controls both. This can affect the employee count used to determine small business eligibility.
Are there special considerations for joint ventures?
Yes. The notice mentions special limits for joint ventures, including restrictions on foreign participation.
Where are applicants directed to find the full eligibility and application requirements?
Applicants are directed to rely on the SF424 (R&R) SBIR/STTR Application Guide for full eligibility and application requirements.
What are the key dates for this solicitation?
The opportunity was posted and created on June 14, 2011. The original and current closing date was September 19, 2011. The archive date was October 20, 2011.
Is this specific funding opportunity still open?
No. Based on the listed closing and archive dates, this specific solicitation is no longer open.
If it is closed, why might this solicitation still be useful?
It can serve as a reference for understanding NIH priorities in neonatal device development and for anticipating similar SBIR topics that may appear in later years.
How is this opportunity categorized?
It is categorized under Health, Income Security, and Social Services.
What CFDA numbers are associated with this program?
Two CFDA numbers are listed: 93.839 (Blood Diseases and Resources Research) and 93.865 (Child Health and Human Development Extramural Research).
Why are there two CFDA numbers?
The CFDA numbers reflect the involvement and mission overlap of NICHD and NHLBI, especially where neonatal monitoring and treatment intersect with cardiopulmonary function, blood oxygenation, and related intensive care needs.
What is the typical project scope implied by the Phase I budget level?
The $250,000 ceiling signals that proposed work should be tightly focused on clear milestones that can be achieved within a Phase I feasibility and proof-of-concept project period.
Where could applicants find the official posting for this announcement?
The announcement indicated there was an NIH grants guide link to the official posting.
Who was listed as a point of contact for technical issues accessing the announcement?
For technical issues accessing the announcement, the notice included contact guidance for the NIH Office of Extramural Research (OER) webmaster.
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Applicants who have applied for this opportunity (RFA HD 12 192) also looked into and applied for these:
| Funding Opportunity |
|---|
| Safe and Effective Instruments and Devices for Use in the Neonatal Intensive Care Units (STTR) R41 Apply for RFA HD 12 193 Funding Number: RFA HD 12 193 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $250,000 |
| Male Reproductive Health Research (MRHR) Career Development Program K12 Apply for RFA HD 12 187 Funding Number: RFA HD 12 187 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $324,000 |
| NICHD Continuing Education Training Programs (T15) Apply for PAR 11 233 Funding Number: PAR 11 233 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $125,000 |
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