Opportunity Information: Apply for RFA HL 15 017
Apply for RFA HL 15 017
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Bioreactors for Reparative Medicine SBIR Direct Phase II (R44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.286 Discovery and Applied Research for Technological Innovations to Improve Human Health 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 $15,975,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $750,000.00 in funding.
- The number of recipients for this funding is limited to 19 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 SBIR Direct Phase II (R44) opportunity (RFA-HL-15-017) is a National Institutes of Health (NIH) grant program focused on pushing tissue growth technology beyond basic culture methods and into more advanced, biomimetic systems that can reliably produce functional tissues. The core problem the solicitation targets is that many promising tissue engineering and regenerative medicine efforts stall because current bioreactors and culture platforms do not reproduce the real, dynamic conditions cells experience in the body. NIH is looking for small businesses to build sophisticated culture systems that give precise, tunable control over cells and the 3D microenvironment, with particular emphasis on matching the distinct physiological demands of heart, lung, and blood-related tissues.
A key theme of the announcement is realism and control: proposed bioreactors should not just keep cells alive, but should actively recreate critical organ-level cues such as mechanical forces, flow and shear, pressure changes, oxygen and nutrient gradients, and other time-varying conditions that drive maturation and function. The intent is to enable more faithful tissue development and better predictive preclinical models, which in turn can improve how technologies transition from research into broader adoption. Because this is a Direct Phase II SBIR mechanism, it is aimed at projects that are beyond the earliest feasibility stage and are ready for more intensive development, engineering refinement, validation, and steps toward translation.
The funding opportunity also places strong weight on quality and standardization because these factors often determine whether a platform is trusted and used in preclinical workflows. Awarded projects are expected to show evidence of developing or operating under Good Laboratory Practice (GLP) standards and/or Good Manufacturing Practice (GMP) standards, as appropriate to the intended use of the technology. In practical terms, this means NIH wants applicants thinking about documentation, process control, reproducibility, and the kinds of quality systems that make a bioreactor credible for regulated or near-regulated environments, not only for exploratory lab demonstrations.
Another requirement is a direct discussion of cell variability and how it will be managed or measured. The solicitation calls out the need to address sources of variability in cell inputs (for example, donor-to-donor differences, batch effects, drift with passage number, differentiation efficiency, or vendor differences) and to connect that discussion to measurement assurance concepts and reference materials. The program is effectively signaling that a successful platform needs not only good biology and good engineering, but also a strategy for calibration, benchmarking, and performance verification so results can be compared across runs, across sites, and potentially across products.
For applicants proposing clinical-grade bioreactors and clinical investigations, the announcement expects early and concrete engagement with the Food and Drug Administration (FDA). Applicants must provide evidence that they have contacted FDA for guidance on the bioreactor device development pathway, which may include correspondence related to an Investigational New Drug (IND) application if relevant, and they should show where the project sits on a timeline aligned with federal regulatory approval processes. This is meant to reduce downstream regulatory surprises by ensuring that design controls, manufacturing approaches, and intended-use claims are being shaped with regulatory feedback in mind from the start.
On the administrative side, this is a discretionary grant under the SBIR Direct Phase II (R44) mechanism. The opportunity was posted July 24, 2014, with an original and final closing date of October 14, 2016, and it was archived November 14, 2016. NIH anticipated up to 19 awards, with an estimated total program funding level of $15,975,000 and an award ceiling of $750,000 per award. There is no cost sharing or matching requirement listed.
Eligibility is limited to U.S. small business concerns (SBCs) that meet SBIR requirements, including being for-profit, having a place of business in the United States and operating primarily in the U.S. (or making a significant contribution to the U.S. economy), fitting an allowed legal structure, and having no more than 500 employees including affiliates. The ownership and control rules follow SBIR standards and include pathways for majority ownership by U.S. citizens or permanent residents, or in certain SBIR-only cases, majority ownership by multiple venture capital operating companies, hedge funds, or private equity firms so long as no single such entity owns more than 50%. Joint ventures can apply if structured to comply with the stated SBIR ownership/control conditions and related registration requirements.
The opportunity is associated with CFDA numbers 93.286 (technological innovations to improve human health) and the heart, lung, and blood research programs 93.837, 93.838, and 93.839, reflecting the clinical areas the bioreactor technologies are expected to serve. The full announcement was hosted through the NIH grants guide under the RFA-HL-15-017 listing, and NIH provided standard contact points for technical issues accessing the posting through the NIH Office of Extramural Research (OER) webmaster.
Frequently Asked Questions (FAQs)
1) What is the name and identifier of this funding opportunity?
This opportunity is titled "Bioreactors for Reparative Medicine SBIR Direct Phase II (R44)" and is identified as RFA-HL-15-017.
2) Which agency is offering this grant?
The program is offered by the National Institutes of Health (NIH).
3) What is the overall purpose of this solicitation?
The solicitation aims to advance tissue growth technology beyond basic cell culture methods by supporting more advanced, biomimetic bioreactor and culture systems that can reliably produce functional tissues. NIH is targeting a known bottleneck: many tissue engineering and regenerative medicine approaches stall because existing culture platforms do not recreate the dynamic conditions cells experience in the body.
4) What kinds of technologies is NIH looking for under this opportunity?
NIH is looking for sophisticated culture systems/bioreactors that provide precise, tunable control over cells and the 3D microenvironment. A major emphasis is on systems that recreate key physiological conditions rather than simply maintaining cell viability.
5) Which tissue or disease areas are emphasized?
The announcement places particular emphasis on the distinct physiological demands of heart, lung, and blood-related tissues.
6) What does "biomimetic" mean in the context of this opportunity?
In this context, "biomimetic" refers to bioreactors that actively recreate organ-level cues found in the body. Examples called out include mechanical forces, flow and shear, pressure changes, oxygen and nutrient gradients, and other time-varying conditions that influence tissue maturation and function.
7) Is the goal only to keep cells alive in culture?
No. The intent is that proposed systems should do more than maintain viability. They should reproduce critical dynamic cues that drive maturation and functional performance of engineered tissues.
8) Why is NIH emphasizing realism and control in bioreactors?
NIH is signaling that tissues grown in systems that better mimic in-body conditions are more likely to develop in a faithful way, which can improve predictive preclinical models and help technologies transition from research settings to broader adoption.
9) What funding mechanism is being used?
This is an SBIR Direct Phase II opportunity under the R44 mechanism.
10) What does "Direct Phase II" imply about project stage?
Based on the description provided, Direct Phase II is aimed at projects that are beyond the earliest feasibility stage and ready for intensive development, including engineering refinement, validation, and steps toward translation.
11) How many awards did NIH anticipate making?
NIH anticipated making up to 19 awards.
12) What was the estimated total program funding?
The estimated total program funding level was $15,975,000.
13) What was the maximum award amount?
The stated award ceiling was $750,000 per award.
14) Is cost sharing or matching required?
No. The information provided states there is no cost sharing or matching requirement listed.
15) When was the opportunity posted, and what were the closing dates?
The opportunity was posted on July 24, 2014. The original and final closing date was October 14, 2016.
16) Is this opportunity still active?
No. It was archived on November 14, 2016, and the final closing date has passed.
17) Who is eligible to apply?
Eligibility is limited to U.S. small business concerns (SBCs) that meet SBIR requirements, including being for-profit, having a place of business in the United States and operating primarily in the U.S. (or making a significant contribution to the U.S. economy), meeting the allowable legal structure requirements, and having no more than 500 employees including affiliates.
18) Do SBIR ownership and control rules apply?
Yes. The opportunity follows standard SBIR ownership and control rules, including majority ownership by U.S. citizens or permanent residents. It also notes that, in certain SBIR-only cases, majority ownership by multiple venture capital operating companies, hedge funds, or private equity firms may be allowed as long as no single such entity owns more than 50%.
19) Can a joint venture apply?
Yes. The information provided indicates that joint ventures can apply if they are structured to comply with the SBIR ownership/control conditions and related registration requirements.
20) What quality expectations (GLP/GMP) does NIH emphasize?
The opportunity places strong weight on quality and standardization. Awarded projects are expected to show evidence of developing or operating under Good Laboratory Practice (GLP) standards and/or Good Manufacturing Practice (GMP) standards, as appropriate to the intended use of the technology. The intent is to support platforms that are credible for regulated or near-regulated environments, not only early exploratory lab work.
21) Why are GLP/GMP considerations important for this program?
Because the solicitation emphasizes that adoption in preclinical workflows often depends on documentation, process control, and reproducibility. These quality system elements can determine whether a platform is trusted and usable for more standardized settings.
22) What does the solicitation require regarding cell variability?
The announcement requires a direct discussion of cell variability and how it will be managed or measured. It calls out sources of variability such as donor-to-donor differences, batch effects, drift with passage number, differentiation efficiency, and vendor differences.
23) How should applicants connect cell variability to measurement and standardization?
The solicitation asks applicants to connect variability discussions to measurement assurance concepts and reference materials, signaling the need for calibration, benchmarking, and performance verification so results can be compared across runs, across sites, and potentially across products.
24) What does NIH expect regarding FDA engagement?
For applicants proposing clinical-grade bioreactors and clinical investigations, NIH expects early and concrete engagement with the Food and Drug Administration (FDA). Applicants must provide evidence they have contacted FDA for guidance on the device development pathway, which may include correspondence related to an Investigational New Drug (IND) application if relevant.
25) What else must be shown if FDA engagement is relevant?
The announcement expects applicants to show where the project sits on a timeline aligned with federal regulatory approval processes, with the goal of reducing downstream regulatory surprises by shaping design controls, manufacturing approaches, and intended-use claims with regulatory feedback.
26) What are the CFDA numbers associated with this opportunity?
The opportunity is associated with CFDA numbers 93.286, 93.837, 93.838, and 93.839.
27) Where was the full announcement hosted?
The full announcement was hosted through the NIH grants guide under the RFA-HL-15-017 listing.
28) Who was listed for technical issues accessing the posting?
NIH provided standard contact points for technical issues accessing the posting through the NIH Office of Extramural Research (OER) webmaster.
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