Opportunity Information: Apply for RFA HL 15 004
Apply for RFA HL 15 004
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Bioreactors for Reparative Medicine (R41/R42)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 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 Jul 24, 2014 and posted on Jul 24, 2014.
- Applicants must submit their applications by Oct 14, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $5,400,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 6 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 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 percent 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 percent 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 percent 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 percent 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:
The Bioreactors for Reparative Medicine (R41/R42) opportunity (RFA-HL-15-004) is an NIH small business grant aimed at pushing tissue growth technology beyond basic culture approaches and toward advanced bioreactor systems that can produce more functional, physiologically relevant tissues. The core problem the program is trying to solve is that many tissue engineering and regenerative medicine efforts are still constrained by rudimentary growth platforms that cannot adequately recreate the complex, dynamic conditions cells experience in the body. In response, the announcement calls for sophisticated, biomimetic culture systems that give researchers precise control over the cellular environment and the three-dimensional microenvironment of engineered tissues, with a specific emphasis on the unique physiological demands of heart, lung, and blood-related tissues.
Projects under this funding opportunity are expected to focus on bioreactor or culture system designs that better mimic real organ conditions, meaning they should address factors like mechanical forces, perfusion and flow, oxygen and nutrient gradients, pressure changes, and other time-varying signals that influence how tissues form and function. The intent is not only to improve tissue formation in the lab, but also to make the resulting platforms more useful and reproducible for preclinical research and, in some cases, to support eventual clinical-grade manufacturing or clinical studies. Because heart, lung, and blood tissues experience distinct dynamics (for example, rhythmic mechanical loading in cardiac tissue, cyclic stretch and air-liquid interface considerations for lung models, and shear stresses and flow conditions relevant to blood and vascular systems), applications should demonstrate that the proposed system is designed around those real physiological constraints rather than offering a generic culture device.
A major theme of the announcement is translational readiness and quality practices. Applicants are expected to show evidence that they are developing or using Good Laboratory Practice (GLP) and/or Good Manufacturing Practice (GMP) standards, since those quality frameworks often determine whether a technology can be trusted, adopted broadly, and used to support regulatory-facing or high-stakes preclinical work. The program also highlights the importance of measurement assurance and reproducibility, asking applicants to discuss sources of cell variability and to consider how reference materials, controls, and standardized measurements could help manage variability and improve confidence in results. In practical terms, this means reviewers are likely to look for plans around calibration, standardized assays, acceptance criteria, batch-to-batch consistency, traceability of materials, and clear documentation practices that make the system more than a one-off prototype.
For applicants proposing clinical-grade bioreactors or clinical investigations, the announcement places an explicit expectation on early regulatory engagement. The applicant must provide evidence of contact with the FDA for guidance on development of the bioreactor device, including relevant correspondence and discussion of how the project fits into a timeline aligned with federal regulatory processes. The example given is communication related to an Investigational New Drug (IND) application, but the broader point is that the project should not treat regulatory considerations as an afterthought. Instead, it should show awareness of the steps and documentation needed for eventual approval pathways, and demonstrate that the company is actively seeking FDA input as it designs and validates the technology.
Administratively, this is a discretionary grant opportunity issued by the National Institutes of Health, tied to multiple CFDA program areas including translational sciences and heart, lung, and blood research (93.350, 93.837, 93.838, 93.839). It uses the SBIR Phased Innovation mechanisms R41/R42, supporting Phase I and Phase II development consistent with small business innovation funding. The opportunity anticipated about six awards with an estimated total funding level of approximately $5.4 million, did not require cost sharing or matching, and was open only to eligible United States small business concerns meeting standard SBIR size and ownership requirements (including the general 500-employee limit and the specified ownership/control structures). The opportunity was posted July 24, 2014, with the final closing date listed as October 14, 2016, and archived November 14, 2016.
Overall, this solicitation is best understood as NIH signaling a need for robust, highly controlled, physiologically faithful bioreactor platforms that can support reparative medicine goals in cardiovascular, pulmonary, and hematologic contexts, while also meeting the practical expectations of quality systems, reproducibility, and (where relevant) early FDA alignment.
Frequently Asked Questions (FAQs) - Bioreactors for Reparative Medicine (R41/R42) (RFA-HL-15-004)
What is the Bioreactors for Reparative Medicine (R41/R42) funding opportunity?
This is an NIH Small Business Innovation Research (SBIR) grant opportunity focused on advancing tissue growth technology beyond basic culture approaches and into more sophisticated, biomimetic bioreactor systems. The goal is to enable production of more functional, physiologically relevant engineered tissues, especially for heart, lung, and blood-related applications.
What problem is this program trying to solve?
The program targets a major limitation in tissue engineering and regenerative medicine: many efforts still rely on rudimentary growth platforms that do not recreate the dynamic, complex conditions cells experience in the body. This limits how well engineered tissues form and function and reduces the usefulness and reproducibility of the resulting models.
What types of projects are expected to be a good fit?
Projects are expected to design or improve bioreactors or culture systems that better mimic real organ conditions. Strong fits include systems that provide precise control over the cellular environment and the three-dimensional microenvironment of engineered tissues, with designs grounded in the physiological demands of heart, lung, and blood/vascular tissues.
What makes a proposed bioreactor "physiologically relevant" under this announcement?
A physiologically relevant system is one that addresses key in vivo-like conditions that influence tissue formation and function. Examples named in the announcement include mechanical forces, perfusion and flow, oxygen and nutrient gradients, pressure changes, and other time-varying signals. The emphasis is on reflecting real physiological constraints rather than offering a generic culture device.
Which tissue areas are specifically emphasized?
The opportunity emphasizes tissues with unique physiological demands tied to heart, lung, and blood-related systems. Applications should show that the proposed design is tailored to those demands rather than being a one-size-fits-all platform.
What kinds of dynamic conditions should heart-focused (cardiac) systems consider?
Cardiac tissues experience rhythmic mechanical loading. Projects should demonstrate that the bioreactor design accounts for these real mechanical dynamics in a way that supports tissue formation and function.
What kinds of dynamic conditions should lung-focused systems consider?
Lung models may need to address cyclic stretch and air-liquid interface considerations. Projects are expected to reflect those physiological features when proposing biomimetic culture platforms.
What kinds of dynamic conditions should blood or vascular-focused systems consider?
Blood and vascular systems are shaped by shear stresses and flow conditions. Proposed culture systems should account for flow-related forces and other relevant dynamics when targeting these tissues.
Is the goal limited to improving tissue formation in the lab?
No. The intent includes improving tissue formation while also making platforms more useful and reproducible for preclinical research. In some cases, projects may also support eventual clinical-grade manufacturing or clinical studies, depending on the project direction described in the application.
How important are quality practices like GLP and GMP for this opportunity?
They are a major theme. Applicants are expected to show evidence that they are developing or using Good Laboratory Practice (GLP) and/or Good Manufacturing Practice (GMP) standards. These quality frameworks affect whether a technology can be trusted, broadly adopted, and used for regulatory-facing or high-stakes preclinical work.
What does the announcement mean by "measurement assurance" and reproducibility?
The program highlights measurement assurance and reproducibility as key expectations. Applicants are asked to discuss sources of cell variability and to consider how reference materials, controls, and standardized measurements can help manage variability and increase confidence in results.
What practical steps might reviewers look for related to reproducibility?
Based on the announcement, reviewers are likely to look for plans and practices such as calibration, standardized assays, acceptance criteria, batch-to-batch consistency, traceability of materials, and clear documentation that supports repeatability and prevents the system from being a one-off prototype.
If a project proposes clinical-grade bioreactors or clinical investigations, what additional expectation applies?
The announcement explicitly expects early regulatory engagement. The applicant must provide evidence of contact with the FDA for guidance on development of the bioreactor device, including relevant correspondence and a discussion of how the project fits a timeline aligned with federal regulatory processes.
What kind of FDA-related evidence is mentioned?
The announcement calls for evidence of FDA contact and includes the example of communication related to an Investigational New Drug (IND) application. The broader expectation is that regulatory considerations are integrated early rather than treated as an afterthought.
Which funding mechanisms are used for this opportunity?
This opportunity uses the SBIR Phased Innovation mechanisms R41/R42, supporting Phase I and Phase II development consistent with small business innovation funding.
Who is eligible to apply?
Eligibility is limited to eligible United States small business concerns that meet standard SBIR size and ownership requirements, including the general 500-employee limit and the specified ownership/control structures.
Is cost sharing or matching required?
No. The opportunity stated that cost sharing or matching was not required.
How many awards and how much total funding were anticipated?
The opportunity anticipated about six awards, with an estimated total funding level of approximately $5.4 million.
Which NIH/CFDA program areas are associated with this solicitation?
The announcement is tied to multiple CFDA program areas including translational sciences and heart, lung, and blood research: 93.350, 93.837, 93.838, and 93.839.
When was this opportunity posted and when did it close?
It was posted on July 24, 2014. The final closing date listed was October 14, 2016. The opportunity was archived on November 14, 2016.
What is the overall takeaway of what NIH is signaling with this solicitation?
NIH is signaling a need for robust, highly controlled, physiologically faithful bioreactor platforms that can support reparative medicine goals in cardiovascular, pulmonary, and hematologic contexts, while also meeting practical expectations around quality systems, reproducibility, and early FDA alignment when clinically relevant.
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