Opportunity Information: Apply for RFA FD 20 027
The Integrated Pathogen Reduction Technologies for whole blood and blood components for transfusion (R01) Clinical Trial Not Allowed funding opportunity (RFA-FD-20-027) is a discretionary grant program from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA), specifically through the Center for Biologics Evaluation and Research (CBER). Its purpose is to advance the development of new or improved pathogen reduction technologies that can be applied to whole blood and to blood components intended for transfusion, with the overall public health goal of preventing transfusion-transmitted infectious diseases. In practical terms, the FDA is looking to support research and development efforts that can reduce or inactivate a broad range of infectious agents that might be present in donated blood, including known pathogens and emerging threats, thereby improving the safety and resilience of the blood supply.
This opportunity uses the R01 grant mechanism and explicitly does not allow clinical trials, meaning the supported work is expected to focus on preclinical research, technology development, optimization, analytical validation, non-clinical performance testing, and other developmental activities that do not meet the definition of a clinical trial. Projects might reasonably include integrated approaches that combine device, chemical, photochemical, or other treatment modalities; engineering and system integration work to make technologies compatible with real-world blood collection and processing workflows; and studies that assess impacts on blood component quality and function. Since pathogen reduction can affect cellular components (like red cells and platelets) as well as plasma proteins, a central theme is likely demonstrating that any pathogen-reduction benefit is achieved while maintaining acceptable blood component integrity, safety characteristics, and expected performance for transfusion use.
The program is listed under CFDA 93.103 and falls within the funding activity category of Agriculture, Consumer Protection, Food and Nutrition, reflecting FDA's regulatory mission and broader public health protection role. Eligibility is broad and includes multiple types of domestic organizations and governmental entities: state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations both with and without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. The inclusion of both nonprofit and for-profit applicants signals that FDA is open to proposals ranging from academic and public-sector laboratory research to industry-led development programs, including translational work that could move a pathogen reduction concept toward a deployable product or system.
From an award standpoint, the opportunity lists an award ceiling of $8,000,000 and anticipates approximately five awards, indicating relatively substantial project budgets and a competitive selection process. The opportunity was created on February 18, 2020, with an original closing date of April 22, 2020. While those dates reflect the specific posting cycle, the content provides a clear snapshot of FDA/CBER priorities: encouraging innovation that strengthens transfusion safety by reducing the risk of infectious disease transmission through whole blood and blood components, and doing so through rigorous development and non-clinical testing pathways rather than human-subject clinical trial work.Apply for RFA FD 20 027
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Integrated Pathogen Reduction Technologies for whole blood and blood components for transfusion (R01) Clinical Trial Not Allowed" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Feb 18, 2020.
- Applicants must submit their applications by Apr 22, 2020. (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 $8,000,000.00 in funding.
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The opportunity is titled "Integrated Pathogen Reduction Technologies for whole blood and blood components for transfusion (R01) Clinical Trial Not Allowed" and is identified as RFA-FD-20-027.
Which federal agency is offering this grant?
This is a discretionary grant program from the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA), through the Center for Biologics Evaluation and Research (CBER).
What is the main purpose of the program?
The purpose is to advance the development of new or improved pathogen reduction technologies that can be applied to whole blood and blood components intended for transfusion, with the public health goal of preventing transfusion-transmitted infectious diseases.
What public health problem is the FDA trying to address through this opportunity?
The program focuses on improving the safety and resilience of the blood supply by reducing or inactivating infectious agents that could be present in donated blood, including both known pathogens and emerging threats.
What grant mechanism does this opportunity use?
This opportunity uses the NIH-style R01 grant mechanism.
Are clinical trials allowed under this funding opportunity?
No. The funding opportunity explicitly states "Clinical Trial Not Allowed," so supported work is expected to avoid activities that meet the definition of a clinical trial.
If clinical trials are not allowed, what kinds of activities are appropriate?
Appropriate activities include preclinical research, technology development, optimization, analytical validation, non-clinical performance testing, and other developmental work that does not meet the definition of a clinical trial.
What types of pathogen reduction technologies are of interest?
The opportunity supports development of pathogen reduction technologies for whole blood and blood components, including integrated approaches that may combine device-based, chemical, photochemical, or other treatment modalities.
Does the opportunity encourage integrated or system-level approaches?
Yes. It references integrated approaches and highlights engineering and system integration work to make technologies compatible with real-world blood collection and processing workflows.
Which blood products or components are within scope?
The scope includes whole blood and blood components intended for transfusion. The description specifically notes impacts on cellular components (such as red cells and platelets) and plasma proteins as key considerations.
Why is blood component quality and function emphasized?
Because pathogen reduction methods can affect cellular components and plasma proteins, a central theme is demonstrating that pathogen reduction benefits are achieved while maintaining acceptable blood component integrity, safety characteristics, and expected performance for transfusion use.
What kinds of pathogens is the program concerned with?
The program aims to reduce or inactivate a broad range of infectious agents that might be present in donated blood, including known pathogens as well as emerging infectious threats.
What is the CFDA number for this program?
The program is listed under CFDA 93.103.
What is the funding activity category associated with this opportunity?
The opportunity is listed under the funding activity category "Agriculture, Consumer Protection, Food and Nutrition," reflecting FDA's public health and regulatory mission.
Who is eligible to apply?
Eligibility is broad and includes many domestic organization types and governmental entities, including state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses.
Can universities and colleges apply?
Yes. Both public/state-controlled institutions of higher education and private institutions of higher education are included in the eligible applicant types.
Can nonprofit organizations apply even if they do not have 501(c)(3) status?
Yes. The eligibility list includes nonprofit organizations with 501(c)(3) status and nonprofit organizations without 501(c)(3) status.
Can for-profit companies apply?
Yes. The eligibility list includes for-profit organizations (other than small businesses) and also separately includes small businesses.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized Native American tribal governments and other tribal organizations are included among eligible applicants.
How many awards does the FDA expect to make?
The opportunity anticipates approximately five awards.
What is the maximum award amount listed for this opportunity?
The award ceiling is listed as $8,000,000.
What does the award ceiling imply about the expected project scale?
An $8,000,000 ceiling and an expected five awards suggest the program is designed for relatively substantial project budgets and that competition for awards may be significant.
When was this funding opportunity created, and what was the original closing date?
The opportunity was created on February 18, 2020, and the original closing date was April 22, 2020.
What is the overall goal of the program in practical terms?
In practical terms, the program supports research and development intended to improve transfusion safety by reducing or inactivating infectious agents in blood, while ensuring blood components remain suitable for transfusion use.
Does the opportunity support work aimed at real-world implementation?
Yes. The description highlights engineering and system integration to ensure compatibility with real-world blood collection and processing workflows, and it also notes translational work that could move a concept toward a deployable product or system.
Does this opportunity focus more on non-clinical development than human-subject testing?
Yes. The program emphasizes rigorous development and non-clinical testing pathways rather than human-subject clinical trial work.
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