Opportunity Information: Apply for RFA HL 14 011

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Onsite Tools and Technologies for Heart, Lung, and Blood Clinical Research Point of Care SBIR (R43/R44)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233 National Center on Sleep Disorders Research 93.350 National Center for Advancing Translational Sciences 93.837 Cardiovascular Diseases Research 93.838 Lung Diseases Research 93.839 Blood Diseases and Resources Research.
  • This funding opportunity was created on Aug 15, 2013 and posted on Aug 15, 2013.
  • Applicants must submit their applications by Oct 15, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Small businesses.
  • Other Eligible Applicants include the following Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
Apply for RFA HL 14 011

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Opportunity Summary:

The grant opportunity titled "Onsite Tools and Technologies for Heart, Lung, and Blood Clinical Research Point of Care SBIR (R43/R44)" (Funding Opportunity Number RFA-HL-14-011) is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) solicitation aimed at moving practical diagnostic and therapeutic-support tools closer to the patient and the clinical care environment. At its core, the FOA is designed to fund research and development that uses advanced technologies to either create new point-of-care (POC) devices or adapt and implement existing technologies so they can be used effectively in real clinical settings. The targeted medical areas are conditions affecting the heart, lungs, and blood, as well as sleep disorders, with an emphasis on tools that can guide clinical decision-making where and when care is delivered rather than relying solely on centralized laboratory testing or offsite analysis.

This opportunity falls under the discretionary grant category and uses the SBIR mechanisms R43 and R44, which generally correspond to the traditional SBIR Phase I (feasibility, early proof-of-concept, and de-risking) and Phase II (continued development, validation, and advancement toward commercialization and broader use). The intent behind using the SBIR program is to encourage small businesses to translate technical innovation into products that can be deployed in healthcare workflows. In practical terms, NIH is signaling interest in devices and systems that can operate onsite, deliver results quickly, and fit the constraints of clinics, hospital units, bedside environments, outpatient settings, and other near-patient locations where speed, usability, and reliability matter.

The technical theme centers on point-of-care tools and technologies that improve how clinicians diagnose, monitor, and treat heart, lung, blood, and sleep-related disorders. While the FOA description is broad, the phrase "guide diagnostic and therapeutic efforts" points to solutions that do more than generate data; they should meaningfully inform clinical action, such as triaging patients, tailoring therapy, monitoring response to treatment, or detecting worsening disease earlier. Technologies could include novel sensing modalities, compact analyzers, miniaturized platforms, integrated sample-to-answer systems, decision-support-enabled devices, or implementations that take an existing technology and make it workable in real-world clinical operations. The emphasis on implementation in clinical settings also implies attention to workflow integration, training requirements, robustness, and the realities of deployment outside specialized research laboratories.

Administratively, the FOA was posted and created on August 15, 2013, with an original and final closing date of October 15, 2015, and it was archived on November 15, 2015. There is no cost sharing or matching requirement, which typically lowers the barrier for small businesses that may not have large amounts of non-federal capital available during early development. Eligibility is limited to small businesses, consistent with SBIR rules. Foreign institutions and non-U.S. entities are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, "foreign components" as defined in the NIH Grants Policy Statement may be allowable, which usually means certain project activities could occur outside the U.S. if they are well-justified and permitted under NIH policy.

The FOA is associated with multiple NIH-related CFDA numbers that reflect the biomedical domains and participating centers involved, including cardiovascular diseases research (93.837), lung diseases research (93.838), blood diseases and resources research (93.839), the National Center on Sleep Disorders Research (93.233), and the National Center for Advancing Translational Sciences (93.350). This mix signals that the opportunity is intentionally cross-cutting: it is anchored in major disease research areas while also aligning with translational goals, meaning the NIH is interested in projects that are not only scientifically sound but also oriented toward practical, usable clinical tools.

For applicants looking for the full official announcement and requirements, the NIH provided an additional information link at http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-14-011.html. For access or technical issues with the online posting, the contact listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV, which is intended for troubleshooting access or linking problems rather than scientific or programmatic guidance.

Overall, this SBIR FOA can be read as NIH support for innovations that shorten the distance between clinical questions and actionable answers in heart, lung, blood, and sleep medicine. The central goal is to enable faster, more informed decisions at the point of care by funding small businesses to develop and clinically implement technologies that work in the environments where patients are actually evaluated and treated.

Frequently Asked Questions (FAQs)

What is the title and funding opportunity number for this grant?

The opportunity is titled "Onsite Tools and Technologies for Heart, Lung, and Blood Clinical Research Point of Care SBIR (R43/R44)" and the Funding Opportunity Number is RFA-HL-14-011.

What kind of grant program is this?

This is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) solicitation. It uses the SBIR award mechanisms R43 and R44.

What do the R43 and R44 mechanisms mean in this opportunity?

R43 and R44 are SBIR mechanisms that generally align with traditional SBIR phases: R43 typically corresponds to Phase I (feasibility and early proof-of-concept work), and R44 typically corresponds to Phase II (continued development, validation, and advancement toward commercialization and broader use).

What is the main purpose of this SBIR funding opportunity?

The purpose is to support research and development that moves practical diagnostic and therapeutic-support tools closer to the patient and the clinical care environment. The FOA focuses on point-of-care (POC) tools and technologies that can be used onsite and can guide clinical decision-making where care is delivered.

What types of medical conditions or clinical areas are targeted?

The targeted areas include conditions affecting the heart, lungs, and blood, as well as sleep disorders. The emphasis is on tools that can improve diagnosis, monitoring, and treatment decisions in these domains.

What does "point of care" mean in the context of this FOA?

In this FOA, point-of-care refers to tools and technologies designed to operate onsite in real clinical environments such as clinics, hospital units, bedside settings, outpatient settings, and other near-patient locations. The intent is to reduce reliance on centralized laboratory testing or offsite analysis when timely clinical decisions are needed.

Is the FOA limited to brand-new devices, or can existing technologies be adapted?

It supports both approaches: developing new point-of-care devices and adapting/implementing existing technologies so they can be used effectively in real clinical settings.

What kind of outcomes is NIH looking for from supported technologies?

The FOA emphasizes solutions that can guide diagnostic and therapeutic efforts, meaning the technology should do more than generate data. Examples described by the FOA include informing clinical action such as triaging patients, tailoring therapy, monitoring response to treatment, or detecting worsening disease earlier.

What kinds of technologies are within scope for this solicitation?

The description is broad, but it points to point-of-care tools and technologies such as novel sensing modalities, compact analyzers, miniaturized platforms, integrated sample-to-answer systems, decision-support-enabled devices, and implementations that make an existing technology workable in real-world clinical operations.

What settings are considered relevant for deployment?

The FOA highlights practical use in clinical care environments, including clinics, hospital units, bedside environments, outpatient settings, and other near-patient locations where speed, usability, and reliability are important.

Does the FOA say anything about workflow or real-world clinical implementation?

Yes. The emphasis on implementing technologies in clinical settings implies attention to workflow integration, training requirements, robustness, and the realities of deployment outside specialized research laboratories.

What grant category does this opportunity fall under?

The opportunity is identified as a discretionary grant.

Who is eligible to apply?

Eligibility is limited to small businesses, consistent with SBIR rules.

Are foreign institutions or non-U.S. entities eligible to apply?

No. Foreign institutions and non-U.S. entities are not eligible to apply. In addition, non-U.S. components of U.S. organizations are not eligible.

Are any foreign activities allowed at all under this FOA?

The FOA notes that "foreign components" as defined in the NIH Grants Policy Statement may be allowable. This generally means certain project activities could occur outside the U.S. if they are well-justified and permitted under NIH policy.

Is cost sharing or matching required?

No. The FOA states there is no cost sharing or matching requirement.

When was this FOA posted and when did it close?

The FOA was posted and created on August 15, 2013. Its original and final closing date was October 15, 2015, and it was archived on November 15, 2015.

Is this funding opportunity still active?

Based on the provided dates, it is not active. It reached its final closing date on October 15, 2015 and was archived on November 15, 2015.

Which CFDA numbers are associated with this FOA?

The FOA is associated with multiple NIH-related CFDA numbers: 93.837 (cardiovascular diseases research), 93.838 (lung diseases research), 93.839 (blood diseases and resources research), 93.233 (National Center on Sleep Disorders Research), and 93.350 (National Center for Advancing Translational Sciences).

What does the mix of CFDA numbers suggest about the opportunity?

The mix indicates the opportunity is cross-cutting, spanning major disease research areas (heart, lung, blood, sleep) while also aligning with translational goals, meaning NIH is interested in projects oriented toward practical, usable clinical tools.

Where can applicants find the official announcement and full requirements?

The NIH provided an additional information link for the full official announcement: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-14-011.html

Who should be contacted for technical problems accessing the online posting?

For access or technical issues with the online posting, the listed contact is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV. This contact is intended for troubleshooting access or linking problems rather than scientific or programmatic guidance.

What is the core goal of this FOA in plain terms?

The FOA aims to shorten the distance between clinical questions and actionable answers in heart, lung, blood, and sleep medicine by funding small businesses to develop and implement point-of-care technologies that work in real clinical environments.

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