Opportunity Information: Apply for RFA HL 15 026
Apply for RFA HL 15 026
- 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 (R41)" 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, 2015. (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 $350,000.00 in funding.
- Eligible applicants include: Independent school districts County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Special district governments Private institutions of higher education State governments Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession 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 must be less than 50 percent participation by foreign business entities in the joint venture 3. i. 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 ii. 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 iii. 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. 4. Has, including its affiliates, not more than 500 employees.
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Opportunity Summary:
Human Cellular Models for Predicting Individual Responses to Cystic Fibrosis Transmembrane Conductance Regulator Directed Therapeutics (R41) is a discretionary NIH grant opportunity from the National Heart, Lung, and Blood Institute (NHLBI) focused on cystic fibrosis (CF) lung disease and, specifically, on improving how well clinicians and developers can anticipate how individual patients will respond to CFTR-targeted therapies. The core idea is to fund the technical development and validation of new in vitro, human cell-based model systems that can serve as practical predictive tools for personalized treatment decision-making and for accelerating therapy development. Rather than emphasizing basic discovery, the program is aimed at building and proving out usable laboratory platforms that can forecast patient-specific responsiveness to CFTR-directed drugs.
This opportunity uses the STTR Phase I mechanism (R41), meaning it is structured to support early-stage, proof-of-concept and feasibility work that is carried out through a formal collaboration between a small business and a nonprofit research institution (the standard STTR model). NHLBI signals that it expects successful projects to reach a level of technical credibility and validation that makes them attractive to outside investors or strategic partners, with the long-range goal of commercialization. In other words, the intended endpoint is not just a publication or a prototype, but a personalized medicine platform that could realistically be productized and adopted, helping CFTR-directed therapies reach the right CF patients faster and more reliably.
The scientific and technical emphasis is on novel human cellular models and associated assays that reflect clinically meaningful CF biology, especially in the airway/lung context, and that can measure or predict differential response across individuals. A strong application under this concept would typically propose a way to generate patient-relevant cells (or tissues) and then quantify CFTR function and drug response in a way that correlates with patient outcomes or known responder status. “Development and validation†is a key phrase in the description: the program is looking for evidence that the tool works as intended and produces reliable, interpretable outputs that can be used to predict therapeutic response at the individual level, not just demonstrate an interesting phenotype in the lab.
From an administrative standpoint, the opportunity is listed under Funding Opportunity Number RFA-HL-15-026, titled as above, with an original posted date of December 3, 2014. The application window closed November 9, 2015, and the opportunity was archived December 10, 2015. The activity category is Health and the CFDA listing is 93.838 (Lung Diseases Research). Cost sharing or matching is not required. The award ceiling is stated as $350,000 (generally meaning the program sets a maximum award amount for the supported budget period under this announcement, subject to NIH policy and the specific FOA terms).
Eligibility is ultimately restricted to United States small business concerns (SBCs), which is consistent with STTR requirements. The announcement text includes a broad set of organizational types in a general eligibility list, but then clarifies that only U.S. SBCs may submit for this opportunity. The SBC definition follows standard federal SBIR/STTR rules: the business must be for-profit, located and operating primarily in the U.S. (or otherwise making a significant contribution to the U.S. economy), organized under an allowable business structure, and have no more than 500 employees including affiliates. Ownership and control requirements are also outlined, including the typical SBIR/STTR conditions around majority ownership by U.S. citizens or permanent residents, as well as certain permitted ownership structures involving venture capital operating companies, hedge funds, or private equity firms (with constraints), and rules for joint ventures.
In practical terms, the opportunity is designed for small businesses building translational tools in the CF space, especially those that can bridge advanced human cell modeling with a clear path to product development. The NHLBI framing makes it clear that it values platforms that are not only scientifically sound but also commercially and operationally plausible: reproducible workflows, measurable performance characteristics, and validation strategies that would convince partners that the tool can support precision use of CFTR modulators (or other CFTR-directed therapeutics) in real-world settings. The overarching public health payoff is a faster, more individualized approach to CFTR-directed treatment, reducing trial-and-error prescribing and potentially improving outcomes for people with CF lung disease by matching therapies to the patients most likely to benefit.
For additional official details, the funding announcement is linked at http://grants.nih.gov/grants/guide/rfa_files/RFA-HL-15-026.html. For access or technical issues with the electronic announcement, NIH directs inquiries to the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The opportunity is titled Human Cellular Models for Predicting Individual Responses to Cystic Fibrosis Transmembrane Conductance Regulator Directed Therapeutics (R41).
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-HL-15-026.
Which federal agency and institute are offering this opportunity?
This is an NIH grant opportunity offered through the National Heart, Lung, and Blood Institute (NHLBI).
What health area does this opportunity focus on?
It focuses on cystic fibrosis (CF) lung disease, with an emphasis on predicting how individual patients respond to CFTR-directed therapeutics.
What is the main goal of the program?
The program aims to fund the technical development and validation of in vitro, human cell-based model systems that can serve as practical tools to predict patient-specific responsiveness to CFTR-targeted therapies.
Is this opportunity focused on basic research or applied development?
It is aimed more at applied development than basic discovery. The emphasis is on building and validating usable laboratory platforms that can forecast individual response to CFTR-directed drugs.
What funding mechanism is used?
This opportunity uses the STTR Phase I mechanism, also known as R41.
What does STTR Phase I (R41) mean in practical terms?
STTR Phase I supports early-stage feasibility and proof-of-concept work and requires a formal collaboration between a U.S. small business and a nonprofit research institution, consistent with the standard STTR model described in the opportunity summary.
What types of projects are especially responsive to this opportunity?
Projects that develop and validate novel human cellular models and related assays that reflect clinically meaningful CF biology (especially in the airway/lung context) and can measure or predict differences in drug response across individuals.
What kinds of model systems does the opportunity emphasize?
It emphasizes in vitro, human cell-based model systems intended to be practical predictive tools for individualized decision-making and therapy development in CF.
What does "development and validation" mean here?
It indicates the program is looking for evidence that the proposed tool not only can be built, but also can be shown to work reliably and produce interpretable outputs that can be used to predict therapeutic response at the individual patient level.
How does the opportunity define a strong application conceptually?
A strong application would typically propose a method to generate patient-relevant cells (or tissues) and quantify CFTR function and drug response in a way that correlates with patient outcomes or known responder status, based on the program description provided.
What is the long-term expectation for successful projects?
NHLBI signals an expectation that successful projects reach technical credibility and validation that make them attractive to outside investors or strategic partners, with the long-range goal of commercialization of a personalized medicine platform.
Is commercialization an explicit program goal?
Yes. The description emphasizes that the intended endpoint is not only a publication or prototype, but a platform that could realistically be productized and adopted to support precision use of CFTR-directed therapeutics.
What is the award ceiling (maximum amount) stated for this opportunity?
The award ceiling is stated as $350,000, generally indicating a maximum award amount for the supported budget period under this announcement (subject to NIH policy and the specific FOA terms).
Is cost sharing or matching required?
No. The opportunity states that cost sharing or matching is not required.
What is the CFDA number associated with this program?
The CFDA listing is 93.838 (Lung Diseases Research).
What is the activity category listed for this opportunity?
The activity category is listed as Health.
Who is eligible to apply?
Eligibility is restricted to United States small business concerns (SBCs), consistent with STTR requirements. While a broad set of organization types may appear in general eligibility lists, the opportunity summary clarifies that only U.S. SBCs may submit.
What are the basic small business requirements mentioned?
The SBC definition follows standard federal SBIR/STTR rules described in the summary: the business must be for-profit, located and operating primarily in the U.S. (or otherwise making a significant contribution to the U.S. economy), organized under an allowable business structure, and have no more than 500 employees including affiliates.
Are there ownership and control requirements?
Yes. The description notes standard SBIR/STTR ownership and control requirements, including majority ownership by U.S. citizens or permanent residents, as well as certain permitted ownership structures involving venture capital operating companies, hedge funds, or private equity firms (with constraints), and rules for joint ventures.
Does the opportunity require collaboration with a research institution?
Yes. Because this is an STTR Phase I (R41) opportunity, it is structured around a collaboration between a small business and a nonprofit research institution, as described in the opportunity summary.
What is the posting date and current status of this opportunity?
The original posted date is December 3, 2014. The application window closed on November 9, 2015, and the opportunity was archived on December 10, 2015.
Is this funding opportunity still open for applications?
No. Based on the dates provided, it closed on November 9, 2015 and was archived on December 10, 2015.
Where can applicants find the official funding announcement?
The official NIH funding announcement is linked at: http://grants.nih.gov/grants/guide/rfa_files/RFA-HL-15-026.html.
Who should be contacted for access or technical issues with the electronic announcement?
NIH directs inquiries about access or technical issues to the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
What is the intended public health impact described for this program?
The stated public health payoff is a faster, more individualized approach to CFTR-directed treatment, reducing trial-and-error prescribing and potentially improving outcomes for people with CF lung disease by better matching therapies to the patients most likely to benefit.
What qualities does NHLBI appear to value in proposed platforms?
The description highlights a preference for platforms that are scientifically sound and also commercially and operationally plausible, including reproducible workflows, measurable performance characteristics, and validation strategies that would convince partners the tool can support precision use of CFTR modulators (or other CFTR-directed therapeutics) in real-world settings.
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