Opportunity Information: Apply for RFA HL 15 027
Apply for RFA HL 15 027
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Human Cellular Models for Predicting Individual Responses to Cystic Fibrosis Transmembrane Conductance Regulator Directed Therapeutics (R43/R44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.838 Lung Diseases Research.
- This funding opportunity was created on Dec 3, 2014 and posted on Dec 3, 2014.
- Applicants must submit their applications by Nov 9, 2016. (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 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 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 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 must be less than 50 percent participation by foreign business entities in the joint venture SBIR and STTR. Be a concern which is more than 50 directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50 directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these OR SBIR only. Be a concern which is more than 50 owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50 of the concern OR SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with 121.705(b) concerning registration and proposal requirements. Has, including its affiliates, not more than 500 employees.
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Opportunity Summary:
The grant opportunity titled "Human Cellular Models for Predicting Individual Responses to Cystic Fibrosis Transmembrane Conductance Regulator Directed Therapeutics (R43/R44)" is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) funding announcement issued through the National Heart, Lung, and Blood Institute (NHLBI). Its main purpose is to drive the commercial development and validation of new laboratory-based, human cell models that can predict how individual cystic fibrosis (CF) patients will respond to drugs that target the cystic fibrosis transmembrane conductance regulator (CFTR). In practical terms, the program is aiming to move personalized medicine for CF lung disease forward by creating in vitro tools that reflect patient-specific biology well enough to help forecast whether a given CFTR-directed therapy is likely to work for a particular person.
The focus on "in vitro human cell based tools" signals that NHLBI is looking for technologies built around human-derived cellular systems rather than animal models or purely computational predictors alone. These tools would ideally be capable of modeling CFTR function and dysfunction in a way that is sensitive to individual differences among patients, including differences driven by CFTR mutations and other patient-specific factors that influence therapeutic response. The intent is not just scientific discovery for its own sake, but the creation of platforms that can be developed into products or services. That commercialization emphasis is central to the SBIR mechanism and is reinforced by the program language stating that successful projects should be positioned to attract strategic partners or investors. In other words, NHLBI is looking for projects that can plausibly reach the market and be adopted in real-world settings, such as drug development pipelines, clinical decision support contexts, or specialized testing services that help match patients to the right CFTR-modulating therapy.
This opportunity uses the SBIR phased structure under the R43/R44 mechanisms, which are commonly used to support small businesses through early feasibility work (Phase I, typically R43) and then through more advanced development and validation steps (Phase II, typically R44). While the announcement summary does not list budget caps or project durations, the R43/R44 framing indicates an expectation that applicants will propose a staged plan that begins with proof-of-concept and proceeds toward a more mature, validated product. The term "validation" in the description also matters: NHLBI is not only interested in building new models, but in demonstrating that they reliably predict patient responses to CFTR-directed therapeutics, which implies comparison against meaningful benchmarks such as known clinical responses, established functional assays, or well-characterized patient samples.
From an administrative standpoint, this is a discretionary grant opportunity in the health research category, tied to CFDA number 93.838 (Lung Diseases Research). It does not require cost sharing or matching funds, which reduces barriers for small businesses that may not have large reserves of capital. The opportunity was posted on December 3, 2014, and the application window ultimately closed on November 9, 2016, with the archive date listed as December 10, 2016. That timeline indicates it is no longer open, but the summary still serves as a useful reference point for the kind of commercialization-oriented translational tools NHLBI has sought in the CF space.
Eligibility is limited to United States small business concerns (SBCs), consistent with SBIR rules. The announcement spells out the standard requirements: the business must be organized for profit, located and operating primarily in the U.S. (or otherwise making a significant contribution to the U.S. economy), and it must fall under an allowable legal structure such as an LLC, corporation, partnership, sole proprietorship, and related forms. It also emphasizes ownership and control requirements that allow for either majority ownership by U.S. citizens or permanent residents, or, in certain SBIR-only circumstances, majority ownership by multiple venture capital operating companies, hedge funds, or private equity firms (with limits on any single entity owning more than 50%). The company must also have no more than 500 employees including affiliates. These details highlight that the program is built specifically to channel federal R&D support into small, commercialization-focused enterprises rather than academic institutions applying as primary applicants, although collaborations with universities and other partners are often part of SBIR project execution.
The practical outcome NHLBI is signaling is the creation of a personalized medicine platform for CF lung disease, with enough technical and commercial readiness to draw follow-on investment and partnerships. In the CFTR-therapeutics context, that suggests tools capable of helping de-risk drug development, stratify patients, or support more individualized selection of CFTR modulators by predicting response before committing to treatment. The announcement frames these tools as a way to accelerate translation of CFTR-directed therapies, meaning faster and more efficient movement from research and development into patient benefit, potentially by identifying responders and non-responders more accurately and earlier.
For further details, the full announcement was hosted on the NIH Grants Guide under the link provided in the source (RFA-HL-15-027). The contact information included is largely technical and administrative, pointing applicants to the NIH Office of Extramural Research (OER) webmaster for access or linking issues, rather than a scientific/research contact listed in the excerpt provided.
Frequently Asked Questions (FAQs)
What is the official title of this grant opportunity?
The opportunity is titled "Human Cellular Models for Predicting Individual Responses to Cystic Fibrosis Transmembrane Conductance Regulator Directed Therapeutics (R43/R44)."
Which agency and institute issued this funding announcement?
This is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) funding announcement issued through the National Heart, Lung, and Blood Institute (NHLBI).
What is the main goal of the program?
The main goal is to drive the commercial development and validation of new laboratory-based, human cell models that can predict how individual cystic fibrosis (CF) patients will respond to drugs that target the cystic fibrosis transmembrane conductance regulator (CFTR). The emphasis is on advancing personalized medicine for CF lung disease using in vitro tools that reflect patient-specific biology.
What kinds of technologies or approaches is NHLBI looking for?
NHLBI is looking for in vitro human cell based tools built around human-derived cellular systems. The intent is to create laboratory models that capture CFTR function and dysfunction in ways that are sensitive to individual patient differences, including differences related to CFTR mutations and other patient-specific factors that influence therapeutic response.
Are animal models or purely computational predictors the focus of this opportunity?
No. The focus is explicitly on in vitro, human cell based tools, which signals a preference for human-derived cellular systems rather than animal models or purely computational predictors alone.
What does "CFTR-directed therapeutics" mean in this context?
In this announcement, CFTR-directed therapeutics are drugs that target the cystic fibrosis transmembrane conductance regulator (CFTR). The proposed models are meant to help forecast whether a given CFTR-targeting therapy is likely to work for a specific individual.
What is meant by "predicting individual responses"?
It refers to developing human cellular models that can forecast patient-specific responses to CFTR-directed therapies, potentially distinguishing likely responders from non-responders based on patient-derived biology.
What does "validation" imply for proposed human cellular models?
Validation implies demonstrating that the models reliably predict patient responses to CFTR-directed therapeutics. The description suggests validation against meaningful benchmarks such as known clinical responses, established functional assays, or well-characterized patient samples.
Is this funding intended for basic research or for commercialization?
The program is commercialization-oriented. While scientific and technical innovation is central, the stated purpose is to create platforms that can be developed into products or services. The announcement highlights that successful projects should be positioned to attract strategic partners or investors.
What are R43 and R44, and how do they relate to the SBIR phases?
R43/R44 are SBIR mechanisms that commonly support projects through a phased structure: Phase I (typically R43) for early feasibility and proof-of-concept work, and Phase II (typically R44) for more advanced development and validation toward a more mature product.
Does the summary provide budget caps or project duration limits?
No. The information provided does not list budget caps or project duration limits, but the R43/R44 framing indicates applicants are expected to propose a staged plan from proof-of-concept toward validation and product readiness.
What real-world uses does NHLBI envision for the resulting tools?
The announcement indicates the tools could plausibly be adopted in settings such as drug development pipelines, clinical decision support contexts, or specialized testing services that help match patients to the right CFTR-modulating therapy.
Who is eligible to apply as the primary applicant?
Eligibility is limited to United States small business concerns (SBCs), consistent with SBIR rules.
What basic organizational requirements must an applicant meet to qualify as an SBIR small business concern?
The business must be organized for profit, located and operating primarily in the U.S. (or otherwise making a significant contribution to the U.S. economy), and formed under an allowable legal structure such as an LLC, corporation, partnership, sole proprietorship, and related forms.
Are there ownership and control requirements for the small business?
Yes. The announcement notes standard SBIR ownership and control rules, including either majority ownership by U.S. citizens or permanent residents, or (in certain SBIR-only circumstances) majority ownership by multiple venture capital operating companies, hedge funds, or private equity firms, with limits on any single entity owning more than 50%.
Is there an employee-size limit for eligible small businesses?
Yes. The company must have no more than 500 employees, including affiliates.
Does this opportunity require cost sharing or matching funds?
No. The information provided states that cost sharing or matching funds are not required.
What is the CFDA number associated with this opportunity?
The opportunity is tied to CFDA number 93.838, identified as Lung Diseases Research.
What type of grant opportunity is this described as?
It is described as a discretionary grant opportunity in the health research category.
When was the opportunity posted, and is it still open?
It was posted on December 3, 2014. The application window closed on November 9, 2016, and the archive date is listed as December 10, 2016. Based on those dates, it is no longer open.
Where was the full funding announcement hosted, and what is the identifier?
The full announcement was hosted on the NIH Grants Guide, and the identifier referenced is RFA-HL-15-027.
What contact information is mentioned in the provided excerpt?
The excerpt indicates that contact information included is largely technical and administrative, pointing applicants to the NIH Office of Extramural Research (OER) webmaster for access or linking issues, rather than listing a scientific/research contact in the provided text.
Are academic institutions allowed to apply as the primary applicant?
The primary applicant is expected to be a small business concern under SBIR rules. The description emphasizes channeling federal R&D support into small, commercialization-focused enterprises rather than academic institutions applying as the primary applicant, though collaborations with universities and other partners are often part of SBIR project execution.
What overall outcome is NHLBI signaling it wants from funded projects?
NHLBI is signaling a desired outcome of a personalized medicine platform for CF lung disease, with enough technical and commercial readiness to attract follow-on investment and partnerships and to accelerate translation of CFTR-directed therapies into patient benefit.
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