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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| FDA's National Curriculum Standard Development and Training Delivery and Development (U18) Clinical Trial Not Allowed Apply for RFA FD 20 024 Funding Number: RFA FD 20 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
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| Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional Apply for RFA FD 20 031 Funding Number: RFA FD 20 031 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $12,000,000 |
| Development and Maintenance of the Animal Feed Regulatory Program Standards with Optional Coordinated Preventive Control Regulatory Activities and Capacity Building (U18) Clinical Trial Not Allowed Apply for PAR 20 132 Funding Number: PAR 20 132 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $600,000 |
| Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional Apply for RFA FD 20 030 Funding Number: RFA FD 20 030 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $12,000,000 |
| Retail Food Safety Association Collaboration (U18) Clinical Trial Not Allowed Apply for RFA FD 20 028 Funding Number: RFA FD 20 028 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Cooperative Agreement to Support FDA Land and Water Initiative (U01) Clinical Trial Not Allowed Apply for RFA FD 20 034 Funding Number: RFA FD 20 034 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Cooperative Agreement to Support an Evidence-based Clinical Practice Guideline for the Treatment of Acute Dental Pain (U01) Clinical Trials Not Allowed Apply for RFA FD 20 029 Funding Number: RFA FD 20 029 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Drug Development Science Support (U01) Clinical Trials Optional Apply for RFA FD 20 033 Funding Number: RFA FD 20 033 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| CBER FY20 FOA for AAV vector manufacturing for diseases affecting very small populations (R01) Clinical Trial Not Allowed Apply for RFA FD 20 032 Funding Number: RFA FD 20 032 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $800,000 |
| Renewal - Federal and University Partnership to Improve the Safety of Seafood from the Gulf of Mexico (U19) Clinical Trials Not Allowed Apply for RFA FD 21 009 Funding Number: RFA FD 21 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $125,000 |
| Renewal - Cooperative Agreement to Support Shellfish Assistance Project (U01) Clinical Trial Not Allowed Apply for RFA FD 21 006 Funding Number: RFA FD 21 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Renewal - Research, Education, and Outreach on Botanical Natural Products (U01) Clinical Trial Not Allowed Apply for RFA FD 21 010 Funding Number: RFA FD 21 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,500,000 |
| Renewal - Strengthen and Promote the Role of Local Health Departments in Retail Food Safety Regulation (U50 Clinical Trial Not Allowed Apply for RFA FD 21 011 Funding Number: RFA FD 21 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $800,000 |
| National Food and Nutrient Analysis Program (U01) Clinical Trial Not Applicable Apply for RFA FD 21 023 Funding Number: RFA FD 21 023 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Advancing Conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) by State, Local, Tribal, and Territorial (SLTT) Retail Food Regulatory Agencies (U2F) Clinical Trials Not Allowed Apply for RFA FD 21 028 Funding Number: RFA FD 21 028 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $10,000,000 |
| Training Alliance to Enhance Produce Safety and FDA Food Safety Modernization Act Compliance (U2F) Clinical Trial Not Allowed Apply for RFA FD 21 024 Funding Number: RFA FD 21 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,600,000 |
| Minor Use Minor Species Development of Drugs (R01) Apply for PAR 21 179 Funding Number: PAR 21 179 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Alliance to Support Integrated Public Health System Activities (U2F) Clinical Trials Not Allowed Apply for RFA FD 21 029 Funding Number: RFA FD 21 029 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| The FDA's Cooperative Agreement Program for States and Territories to Implement a National Produce Safety Program (U2F) Clinical Trials Not Allowed Apply for PAR 21 174 Funding Number: PAR 21 174 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $12,500,000 |
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