Opportunity Information: Apply for RFA HL 15 030
Apply for RFA HL 15 030
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Stem Cell Derived Blood Products for Therapeutic Use Technology Improvement (R43/R44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.839 Blood Diseases and Resources Research.
- This funding opportunity was created on Nov 7, 2014 and posted on Nov 7, 2014.
- Applicants must submit their applications by Feb 20, 2017. (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 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:
The grant opportunity titled "Stem Cell Derived Blood Products for Therapeutic Use Technology Improvement (R43/R44)" (Funding Opportunity Number RFA-HL-15-030) is a National Institutes of Health (NIH) small business-focused funding announcement aimed at moving stem cell-based blood product manufacturing closer to real-world clinical and commercial use. The central purpose is to fund technology development that makes it easier, faster, and less expensive to produce clinically relevant, functional red blood cells or platelets that are derived from stem cells. In practical terms, the opportunity targets the engineering and process-development challenges that currently make stem cell derived blood components difficult to manufacture at scale, and it encourages applicants to build better tools, methods, and production workflows that can yield therapeutic-grade products reliably.
The scientific and technical emphasis is on improving the efficiency and cost-effectiveness of producing functional stem cell derived red blood cells and platelets, not merely proving a biological concept in a lab dish. NIH is signaling interest in enabling technologies that solve key bottlenecks in manufacturing, consistency, and performance of the final cell product, with an eye toward products that could eventually be used in patients. The announcement highlights "clinically relevant" and "functional" outputs, which implies that proposed approaches should be oriented toward qualities that matter for therapeutic use, such as the ability of red blood cells to perform oxygen transport functions appropriately or the ability of platelets to contribute to clotting function, along with characteristics that support translation such as reproducibility, scalability, and compatibility with quality-controlled production.
This is a discretionary grant program using the SBIR/STTR-style phased funding mechanism indicated by the R43/R44 activity codes. R43 is generally associated with Phase I (early feasibility and proof-of-concept work), and R44 is generally associated with Phase II (more advanced development and demonstration, often including prototype/process refinement and steps toward commercialization). The structure is intended for small companies that can take an applied research idea and push it toward a productized, deployable technology, rather than for purely academic exploratory research. The description also explicitly frames the expected outcome as technologies that "enable the production of functional stem cell based therapies with potential commercial and clinical viability," underscoring that the endgame is manufacturable therapeutic products or the platform capabilities needed to produce them.
Eligibility is limited to United States small business concerns (SBCs). To qualify, an applicant organization must be for-profit, have a place of business in the United States, and operate primarily in the United States (or make a significant contribution to the U.S. economy through taxes or the use of American products, materials, or labor). Acceptable legal forms include sole proprietorships, partnerships, limited liability companies, corporations, joint ventures, associations, trusts, and cooperatives, with additional restrictions for joint ventures including limits on foreign participation. Ownership and control requirements follow SBIR/STTR rules, including pathways that allow majority ownership by U.S. citizens or permanent residents and, for SBIR in particular, certain configurations of venture capital operating companies, hedge funds, and private equity firms, with the constraint that no single such entity may own more than 50 percent of the company. The company must also have no more than 500 employees including affiliates. The funding opportunity does not require cost sharing or matching, which can be important for early-stage companies that may not have substantial non-dilutive capital available.
From an administrative standpoint, the opportunity falls under the Health funding activity category and is associated with CFDA number 93.839, Blood Diseases and Resources Research, indicating the programmatic home within NIH’s blood-related research portfolio. The opportunity was posted on November 7, 2014, and the original and current closing date listed is February 20, 2017, with an archive date of March 23, 2017, meaning it is no longer active for new submissions under that specific announcement. The sponsoring agency is NIH, and the full announcement was hosted on the NIH grants guide site. For access or technical issues related to the posting, the contact point provided is the NIH Office of Extramural Research (OER) Webmaster (FBOWebmaster@OD.NIH.GOV).
Overall, this funding announcement is best understood as a targeted SBIR/STTR-style call for small businesses to build and refine the practical manufacturing technologies needed to generate therapeutic-grade red blood cells and platelets from stem cells, with strong emphasis on performance, efficiency, and cost reduction so that stem cell derived blood products can become more feasible for clinical translation and eventual commercialization.
Frequently Asked Questions (FAQs)
What is the official title of this grant opportunity?
The opportunity is titled "Stem Cell Derived Blood Products for Therapeutic Use Technology Improvement (R43/R44)."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-HL-15-030.
Which agency is sponsoring this funding opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What type of funding mechanism does this opportunity use?
It uses the SBIR/STTR-style phased mechanism indicated by the R43/R44 activity codes.
What do the R43 and R44 activity codes mean in practical terms?
R43 generally corresponds to Phase I work (early feasibility and proof-of-concept). R44 generally corresponds to Phase II work (more advanced development and demonstration, including refinement toward a deployable product or process).
What is the central purpose of this funding announcement?
The purpose is to support technology development that makes it easier, faster, and less expensive to produce clinically relevant, functional red blood cells or platelets derived from stem cells, and to move stem cell-based blood product manufacturing closer to real-world clinical and commercial use.
What kinds of products or outputs is NIH specifically interested in?
The emphasis is on producing functional stem cell-derived red blood cells and platelets intended for therapeutic use, along with the manufacturing technologies, tools, methods, and workflows needed to produce them reliably.
Is this opportunity focused on basic biology or manufacturing technology?
It is focused on technology improvement and process development for manufacturing, including efficiency, cost-effectiveness, consistency, and performance of the final cell product, rather than on purely demonstrating a biological concept in a laboratory setting.
What does NIH mean by "clinically relevant" and "functional" blood products in this announcement?
The description signals that proposed approaches should target qualities that matter for therapeutic use. Examples mentioned include red blood cell oxygen transport function and platelet clotting-related function, alongside translation-oriented characteristics such as reproducibility, scalability, and compatibility with quality-controlled production.
What problem is NIH trying to solve with this funding opportunity?
The opportunity targets engineering and process-development bottlenecks that make stem cell-derived blood components difficult to manufacture at scale, and encourages applicants to develop better production methods that can yield therapeutic-grade products reliably.
Who is eligible to apply?
Eligibility is limited to United States small business concerns (SBCs).
What are the basic organizational requirements for an eligible small business concern?
The applicant organization must be for-profit, have a place of business in the United States, and operate primarily in the United States (or make a significant contribution to the U.S. economy through taxes or the use of American products, materials, or labor).
What legal business structures are acceptable for applicants?
Acceptable forms include sole proprietorships, partnerships, limited liability companies (LLCs), corporations, joint ventures, associations, trusts, and cooperatives, with additional restrictions for joint ventures including limits on foreign participation.
Are there ownership and control requirements?
Yes. Ownership and control follow SBIR/STTR rules, including pathways allowing majority ownership by U.S. citizens or permanent residents and, for SBIR, certain ownership structures involving venture capital operating companies, hedge funds, and private equity firms, with the constraint that no single such entity may own more than 50 percent of the company.
Is there a size limit for the applying company?
Yes. The company must have no more than 500 employees, including affiliates.
Does this opportunity require cost sharing or matching funds?
No. The announcement states that cost sharing or matching is not required.
What is the expected outcome NIH is looking for from funded projects?
The expected outcome is technologies that enable the production of functional stem cell-based therapies with potential commercial and clinical viability, meaning advances that can support manufacturable therapeutic products or the platform capabilities needed to produce them.
Is this opportunity intended for academic exploratory research projects?
The framing emphasizes small businesses advancing applied research toward productized, deployable technology, rather than purely academic exploratory research.
What is the funding activity category for this opportunity?
The funding activity category is Health.
What CFDA number is associated with this opportunity?
The CFDA number is 93.839, Blood Diseases and Resources Research.
When was the opportunity posted?
The opportunity was posted on November 7, 2014.
What was the closing date for submissions under this specific announcement?
The listed closing date is February 20, 2017 (the same date is shown as both the original and current closing date).
Is this funding opportunity still active?
No. An archive date of March 23, 2017 is listed, indicating it is no longer active for new submissions under that specific announcement.
Where was the full announcement hosted?
The full announcement was hosted on the NIH grants guide site.
Who should be contacted for access or technical issues related to the posting?
The contact listed for access or technical issues is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
What types of blood components are specifically called out?
Red blood cells and platelets derived from stem cells are specifically identified as the targeted blood products.
What aspects of production does the opportunity emphasize improving?
The announcement emphasizes improvements in efficiency and cost-effectiveness, and it highlights manufacturing-relevant issues such as consistency, reproducibility, scalability, performance of the final cell product, and compatibility with quality-controlled production.
What is the overall way to interpret this funding call?
It is best understood as a targeted SBIR/STTR-style NIH call for small businesses to build and refine practical manufacturing technologies needed to generate therapeutic-grade red blood cells and platelets from stem cells, with a strong emphasis on performance, efficiency, and cost reduction to support clinical translation and eventual commercialization.
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