Opportunity Information: Apply for RFA HL 15 029
Apply for RFA HL 15 029
- 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 (R41)" 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, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $675,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $225,000.00 in funding.
- The number of recipients for this funding is limited to 3 candidate(s).
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following 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:
Stem Cell Derived Blood Products for Therapeutic Use Technology Improvement (R41) is an NIH small business grant opportunity (Funding Opportunity Number RFA HL 15 029) focused on strengthening the technologies needed to manufacture stem cell derived blood products, specifically red blood cells and platelets, for real therapeutic use. The core aim is not basic biology for its own sake, but practical technology improvement: developing better methods, tools, and production approaches that make these cell products more clinically relevant, reliably functional, easier to produce at scale, and ultimately less expensive. The opportunity is framed around moving the field closer to stem cell based blood therapies that are realistic for commercial development and eventual clinical adoption, which implies an emphasis on manufacturability, reproducibility, and performance of the final cell products.
The funded work is expected to target clear bottlenecks in producing functional stem cell derived red blood cells or platelets. In plain terms, NIH is signaling interest in innovations that increase efficiency and reduce cost while maintaining or improving quality, such as improving differentiation and maturation processes, increasing yield, improving product consistency, or enabling production systems that can scale beyond small laboratory batches. Because the announcement emphasizes "clinically relevant" and "functional" products, projects would be expected to keep their eye on end use requirements like biological activity, reliability, and suitability for therapeutic settings, rather than generating cells that only look correct under a microscope but do not perform well enough for transfusion type applications.
This is a discretionary grant mechanism using the SBIR Phase I format (R41), which is designed to support early stage feasibility and proof of concept work in small businesses. The sponsoring agency is the National Institutes of Health, and the program is associated with CFDA 93.839 (Blood Diseases and Resources Research), reflecting its connection to blood related disorders, transfusion science, and biomedical resources. The intent is to help companies de risk and advance enabling technologies that could later progress toward broader development, regulatory preparation, and commercialization pathways.
Funding for the opportunity was relatively targeted and competitive. NIH anticipated about three awards, with an estimated total funding amount of $675,000. The award ceiling was $225,000, and there was no cost sharing or matching requirement, which is typical for many NIH SBIR opportunities and lowers the barrier for small companies to propose high impact early development work. The posting and creation dates were November 7, 2014, with an original and current closing date of February 20, 2015, and an archive date of March 23, 2015, meaning the specific solicitation is no longer active but still useful as a reference point for similar future NIH topics.
Eligibility was limited to small businesses, consistent with SBIR rules. To qualify, an applicant needed to be a for profit entity with a place of business in the United States and operations primarily in the U.S. (or otherwise making a significant contribution to the U.S. economy through taxes or use of American products, materials, or labor). The business could take common legal forms such as a sole proprietorship, partnership, LLC, corporation, joint venture, association, trust, or cooperative, with the additional condition that joint ventures must have less than 50 percent foreign business entity participation. The company also had to meet the SBIR size standard of no more than 500 employees including affiliates. Ownership and control requirements followed SBIR policy, including pathways for majority ownership by U.S. citizens or permanent residents, and, for SBIR only, certain structures allowing majority ownership by multiple venture capital operating companies, hedge funds, or private equity firms so long as no single one owned more than 50 percent. Joint ventures were also permitted if each participant met the relevant SBIR ownership requirements, with additional registration and proposal rules applying in certain cases.
For applicants trying to understand the practical emphasis of this opportunity, the key message is that NIH wanted tools and techniques that move stem cell derived blood components toward real world use: better production efficiency, better cost profile, and better functional performance suitable for therapeutic contexts, with a clear line of sight to commercial viability. The official announcement was hosted by NIH and referenced via the additional information link (http://grants.nih.gov/grants/guide/rfa_files/RFA-HL-15-029.html). For access issues or linking problems, NIH directed applicants to the NIH Office of Extramural Research webmaster contact (FBOWebmaster@OD.NIH.GOV).
Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
The opportunity is titled "Stem Cell Derived Blood Products for Therapeutic Use Technology Improvement (R41)".
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA HL 15 029 (often formatted as RFA-HL-15-029).
What type of grant mechanism is this?
This is an NIH SBIR Phase I opportunity using the R41 mechanism, intended for early-stage feasibility and proof-of-concept work in small businesses.
Which agency sponsors this opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What program area is this associated with (CFDA number)?
This opportunity is associated with CFDA 93.839, described as Blood Diseases and Resources Research.
What is the main goal of the funding opportunity?
The main goal is to strengthen and improve technologies needed to manufacture stem cell-derived blood products, specifically red blood cells and platelets, in ways that support real therapeutic use.
Is the focus on basic biology research or on applied technology development?
The emphasis is on practical technology improvement rather than basic biology for its own sake. The intent is to develop methods, tools, and production approaches that make stem cell-derived blood products more clinically relevant and commercially realistic.
Which blood products are specifically targeted?
The announcement specifically targets stem cell-derived red blood cells and stem cell-derived platelets.
What kinds of technical improvements is NIH looking for?
Projects are expected to address clear bottlenecks in producing functional products, such as:
- Improving differentiation and maturation processes
- Increasing yield
- Improving product consistency and reproducibility
- Enabling production systems that can scale beyond small laboratory batches
- Reducing cost while maintaining or improving product quality
What does "clinically relevant" and "functional" mean in the context of this opportunity?
It signals an expectation that resulting cell products should be geared toward therapeutic settings, with attention to biological activity, reliability, and suitability for transfusion-type applications, not just cells that look correct in laboratory characterization.
How many awards did NIH anticipate making?
NIH anticipated making about three awards.
What was the estimated total funding amount for this solicitation?
The estimated total funding amount was $675,000.
What was the maximum award amount (award ceiling)?
The award ceiling was $225,000.
Was cost sharing or matching required?
No. The opportunity stated there was no cost sharing or matching requirement.
Who was eligible to apply?
Eligibility was limited to small businesses, consistent with SBIR rules.
What are the basic SBIR small business requirements mentioned?
Based on the description provided, applicants needed to meet these baseline SBIR conditions:
- Be a for-profit entity
- Have a place of business in the United States
- Have operations primarily in the U.S., or otherwise make a significant contribution to the U.S. economy (through taxes or use of American products, materials, or labor)
- Meet the SBIR size standard of no more than 500 employees (including affiliates)
What legal business structures were allowed to apply?
The opportunity indicated that eligible businesses could include common legal forms such as a sole proprietorship, partnership, LLC, corporation, joint venture, association, trust, or cooperative.
Are joint ventures allowed?
Yes. Joint ventures were allowed, with the stated condition that joint ventures must have less than 50 percent foreign business entity participation. The description also notes that additional registration and proposal rules can apply in certain joint venture cases.
What ownership and control rules were highlighted?
The description notes SBIR ownership and control requirements, including:
- Pathways for majority ownership by U.S. citizens or permanent residents
- For SBIR only, certain structures allowing majority ownership by multiple venture capital operating companies, hedge funds, or private equity firms, as long as no single one owns more than 50 percent
- Joint ventures are permitted if each participant meets relevant SBIR ownership requirements
What was the timeline for this specific solicitation?
The posting/creation date was November 7, 2014. The original and current closing date was February 20, 2015. The archive date was March 23, 2015.
Is this funding opportunity still active?
No. The solicitation is no longer active because it has a past closing date and is listed as archived.
If it is archived, why might it still be useful?
The information indicates it can still serve as a reference point for similar future NIH topics, especially for companies working on manufacturable, scalable stem cell-derived red blood cell or platelet technologies.
What is the practical message NIH is sending to applicants through this topic?
The practical message is to keep a strong line of sight to real-world use and commercial viability by improving manufacturability, reproducibility, scalability, cost profile, and functional performance of the final cell products.
Where was the official announcement hosted?
The official announcement was hosted by NIH at: http://grants.nih.gov/grants/guide/rfa_files/RFA-HL-15-029.html
Who should be contacted if there are access issues with the official link?
For access issues or linking problems, NIH directed users to contact the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.
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