Opportunity Information: Apply for RFA HD 12 193
Apply for RFA HD 12 193
- 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 (STTR) R41" 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.)
- Each selected applicant is eligible to receive up to $250,000.00 in funding.
- 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, 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 (STTR) R41" (Funding Opportunity Number: RFA-HD-12-193) is a National Institutes of Health (NIH) Small Business Technology Transfer (STTR) Phase I grant solicitation focused on improving the safety and performance of medical technology used for newborns and very young children. It is sponsored by two NIH institutes: the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Heart, Lung, and Blood Institute (NHLBI). The central goal is to support early-stage, high-impact research and development that either creates new instruments and devices or meaningfully improves existing ones used to monitor and treat infants and small children, especially in Neonatal Intensive Care Unit (NICU) settings where patients are medically fragile and tolerances for risk are extremely low.
This opportunity sits in the broader health and human services research category and is tied to CFDA program areas 93.865 (Child Health and Human Development Extramural Research) and 93.839 (Blood Diseases and Resources Research). In practical terms, applicants are being asked to propose technology development projects that address real clinical needs in neonatal and pediatric critical care, including monitoring, diagnosis, and therapeutic support. The emphasis on "safe and effective" underscores that neonatal devices cannot simply be scaled-down versions of adult tools; they must account for neonatal physiology, skin fragility, tiny anatomy, immature organ systems, and the heightened risks associated with invasive procedures, blood loss, infection, heat loss, and incorrect dosing or measurement. Projects responsive to this kind of solicitation typically aim to reduce complications, improve accuracy and reliability of measurements, lessen invasiveness, and make devices easier for clinicians to use correctly in high-stakes environments.
The award mechanism is an STTR Phase I (R41), which generally supports feasibility and proof-of-concept work conducted through a formal collaboration between a small business and a nonprofit research institution. While the notice excerpt does not spell out the required work split, STTR programs typically require a meaningful research role for the partnering institution and a structured plan for translating the research into a product or clinical tool. The maximum award amount listed is an award ceiling of $250,000, and there is no cost-sharing or matching requirement, meaning applicants are not required to bring non-federal matching funds to be eligible.
Eligibility is limited to United States small business concerns (SBCs). To qualify, a company must be organized for profit, have a place of business in the United States, and operate primarily in the U.S. or contribute significantly to the U.S. economy through taxes or the use of American products, materials, or labor. The business must also be in an acceptable legal form (such as a sole proprietorship, partnership, LLC, corporation, joint venture, association, trust, or cooperative), and it must be at least 51% owned and controlled by one or more U.S. citizens or permanent resident aliens. The company, including affiliates, must have no more than 500 employees. The announcement also highlights affiliate rules drawn from federal small business regulations (13 C.F.R. Part 121), which can affect size status when control relationships exist between entities. Applicants are directed to use the SF424 (R&R) SBIR/STTR Application Guide for the detailed eligibility and application requirements.
Key dates associated with this archived opportunity include a posted and creation date of June 14, 2011, with an original and current closing date of September 19, 2011, and an archive date of October 20, 2011. The opportunity category is listed as discretionary, the funding instrument is a grant, and the activity category is health-related income security and social services. For full details, the original NIH posting is referenced through an additional information link at grants.nih.gov (RFA-HD-12-193). For technical issues accessing the announcement, the NIH Office of Extramural Research (OER) webmaster contact is provided.
In summary, this STTR Phase I grant call was designed to help U.S. small businesses, working collaboratively with research institutions, develop and refine NICU-relevant devices and instruments that can improve how newborns and small children are monitored and treated. The funding is intended to move promising ideas through early feasibility work toward safer, more reliable, and more clinically appropriate tools for neonatal and pediatric care, with a clear translation focus consistent with NIH small business programs.
Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The funding opportunity is titled "Safe and Effective Instruments and Devices for Use in the Neonatal Intensive Care Units (STTR) R41."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-HD-12-193.
Which agencies or institutes sponsor this opportunity?
This is a National Institutes of Health (NIH) opportunity sponsored by two NIH institutes: the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Heart, Lung, and Blood Institute (NHLBI).
What type of program is this (SBIR vs. STTR)?
This is an NIH Small Business Technology Transfer (STTR) solicitation.
What project phase does this opportunity support?
This opportunity supports STTR Phase I projects, using the R41 activity code, which generally focuses on feasibility and proof-of-concept work.
What is the main goal of the program?
The central goal is to support early-stage, high-impact research and development that creates new instruments and devices or meaningfully improves existing ones used to monitor and treat newborns and very young children, especially in Neonatal Intensive Care Unit (NICU) settings where patients are medically fragile and tolerances for risk are extremely low.
What kinds of technologies are the focus of this solicitation?
The focus is on medical technology used to monitor, diagnose, and provide therapeutic support for infants and small children in neonatal and pediatric critical care settings, particularly the NICU.
Why does the opportunity emphasize "safe and effective" device design for neonates?
The solicitation highlights that neonatal devices cannot simply be scaled-down adult tools. They must account for neonatal physiology and risks such as skin fragility, tiny anatomy, immature organ systems, and elevated risks from invasive procedures, blood loss, infection, heat loss, and incorrect dosing or measurement.
What types of improvements are encouraged for NICU-relevant devices?
Projects responsive to this solicitation typically aim to reduce complications, improve accuracy and reliability of measurements, lessen invasiveness, and make devices easier for clinicians to use correctly in high-stakes NICU environments.
What is the award mechanism and funding instrument?
The award mechanism is STTR Phase I (R41), and the funding instrument is a grant.
What is the maximum award amount?
The listed award ceiling is $250,000.
Is cost-sharing or matching required?
No. The opportunity states there is no cost-sharing or matching requirement, meaning applicants are not required to provide non-federal matching funds to be eligible.
Who is eligible to apply?
Eligibility is limited to United States small business concerns (SBCs) that meet the requirements described in the announcement and related federal regulations.
What are the basic small business concern (SBC) eligibility requirements mentioned?
To qualify, the business must be organized for profit, have a place of business in the United States, and operate primarily in the U.S. or contribute significantly to the U.S. economy through taxes or the use of American products, materials, or labor.
What legal forms of business are considered acceptable under this opportunity?
The announcement indicates acceptable legal forms can include a sole proprietorship, partnership, LLC, corporation, joint venture, association, trust, or cooperative.
What ownership and control requirements apply?
The small business must be at least 51% owned and controlled by one or more U.S. citizens or permanent resident aliens.
Is there an employee size limit for eligibility?
Yes. The company, including affiliates, must have no more than 500 employees.
Do affiliate relationships matter for determining eligibility?
Yes. The announcement notes that affiliate rules from federal small business regulations (13 C.F.R. Part 121) can affect size status when control relationships exist between entities.
Does this opportunity require collaboration with a nonprofit research institution?
Yes. The STTR Phase I mechanism generally supports feasibility work conducted through a formal collaboration between a small business and a nonprofit research institution, with a meaningful research role for the partnering institution and a structured plan for translating the research into a product or clinical tool.
Which application guide is referenced for detailed requirements?
Applicants are directed to use the SF424 (R&R) SBIR/STTR Application Guide for detailed eligibility and application requirements.
What are the CFDA program areas associated with this opportunity?
This opportunity is tied to CFDA 93.865 (Child Health and Human Development Extramural Research) and CFDA 93.839 (Blood Diseases and Resources Research).
When was this opportunity posted and when did it close?
The posted and creation date is June 14, 2011. The original and current closing date is September 19, 2011.
Is this an active funding opportunity?
No. The opportunity is described as archived, with an archive date of October 20, 2011.
What is the opportunity category and activity category?
The opportunity category is listed as discretionary, and the activity category is described as health-related income security and social services.
Where can applicants find the original NIH posting for full details?
The announcement references an NIH link at grants.nih.gov for RFA-HD-12-193 as the source for full details.
Who is listed as the contact for technical issues accessing the announcement?
For technical issues accessing the announcement, the NIH Office of Extramural Research (OER) webmaster contact is provided.
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