Opportunity Information: Apply for RFA FD 19 002
The grant opportunity "Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity" (RFA-FD-19-002) is a U01 cooperative agreement from the U.S. Food and Drug Administration (FDA) under the Department of Health and Human Services. It is aimed at improving how drug developers detect and predict cardiac safety problems earlier and more reliably, with a particular focus on human biology-based test systems rather than traditional animal-only approaches. The central problem motivating the program is that cardiovascular toxicity remains one of the most common reasons otherwise promising drug candidates fail during development, which wastes time and money and can prevent beneficial therapies from reaching patients.
A major emphasis of the opportunity is on arrhythmia-related liabilities that drive regulatory and industry concern, especially proarrhythmia, QT interval prolongation, and the potentially fatal arrhythmia Torsade de Pointes (TdP). These issues have historically been managed through a combination of nonclinical in vivo studies and a dedicated clinical evaluation known as the thorough-QT (TQT) study. While that paradigm has helped reduce risk, it is expensive and time-consuming, and it can still miss certain human-specific effects or generate results that do not translate cleanly from animals to humans. FDA is therefore seeking newer assays that can either replace or substantially improve the current nonclinical cardiotoxicity assessment toolbox, with the longer-term goal of enabling better predictions of clinical risk before a compound reaches late-stage development.
The scientific direction highlighted in the announcement centers on assays based on human cells or human-derived materials, specifically human stem cell-derived cardiomyocytes. The intent is to validate these technologies for their ability to capture a broad spectrum of drug-induced cardiac effects, not only a narrow endpoint like QT prolongation. In practical terms, this means developing and rigorously evaluating experimental systems that use human cardiomyocytes to measure electrophysiologic and functional responses to drugs, demonstrating that those responses are reproducible, interpretable, and meaningfully predictive of clinically relevant cardiac toxicity. Because the title uses the word "validating," the opportunity is not merely about creating a novel assay in concept, but about showing through systematic testing that the assay performs well enough to be trusted for decision-making in drug development.
This is a cooperative agreement (U01), which typically implies substantial scientific or programmatic involvement from the FDA during the project period. Rather than functioning like a standard investigator-initiated grant where the awardee largely sets the direction after funding, a U01 mechanism commonly includes ongoing collaboration, milestone-driven progress, and coordination with agency priorities such as standardization, benchmarking, and the generation of data that can inform regulatory science. The notice also specifies "Clinical Trial Not Allowed," which signals that the funded work should remain in the nonclinical or preclinical space and should not involve prospective assignment of human participants to interventions to study health outcomes.
From an administrative standpoint, the opportunity was posted with a creation date of January 31, 2019, and an original application closing date of April 4, 2019. The expected number of awards was one, with an award ceiling of $1,500,000, indicating a single, relatively substantial project rather than multiple smaller awards. The eligible applicant pool is broad and includes state and local governments, public and private institutions of higher education, independent school districts, federally recognized tribal governments and certain tribal organizations, nonprofit organizations (both 501(c)(3) and non-501(c)(3)), small businesses, and other entities as described in the full eligibility language. The funding activity is categorized under areas that include consumer protection and food and nutrition, consistent with FDA's public health mission and regulatory science role.
In summary, this funding opportunity is designed to accelerate the acceptance and practical utility of human stem cell-derived cardiomyocyte platforms as predictive tools for drug-induced cardiac toxicity. By supporting rigorous validation work under a collaborative FDA-led framework, the program aims to reduce late-stage drug failures driven by proarrhythmia risk, improve the relevance of nonclinical testing to human outcomes, and ultimately modernize the cardiac safety assessment pipeline with assays that better reflect human physiology.Apply for RFA FD 19 002
- 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 "Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity (U01 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 Jan 31, 2019.
- Applicants must submit their applications by Apr 04, 2019. (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 $1,500,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: State governments, City or township governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), 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, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01) Clinical Trial Optional Apply for RFA FD 19 005 Funding Number: RFA FD 19 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01- Clinical Trial Required) Activity Code Apply for RFA FD 19 014 Funding Number: RFA FD 19 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Bioequivalence of Topical Products: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 008 Funding Number: RFA FD 19 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Bioequivalence of Topical Products: Elucidating the Sensorial and Functional Characteristics of Compositionally Different Topical Formulations (U01 Clinical Trial Required) Apply for RFA FD 19 009 Funding Number: RFA FD 19 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 010 Funding Number: RFA FD 19 010 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 the Illinois Institute of Technology's Institute for Food Safety and Health (U19 Clinical Trial Optional) Apply for RFA FD 19 003 Funding Number: RFA FD 19 003 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $10,000,000 |
| Enhancing Regulatory Science for the Risk Based Quality Assessment of Complex Products (U01) - Clinical Trials Optional Apply for RFA FD 19 011 Funding Number: RFA FD 19 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| Advancing Post-Market Surveillance of High-Risk Facilities and Products through Signal detection, Data analysis, and the Review of the State of Quality (U01) Clinical Trial Optional Apply for PAR 19 190 Funding Number: PAR 19 190 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
| Advancing Manufacturing Processing and Control Strategies for Drug Substances and Drug Products (U01)- Clinical Trial Optional Apply for PAR 19 216 Funding Number: PAR 19 216 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $6,000,000 |
| Implementation of the Animal Feed Regulatory Program Standards (U18 Clinical Trial Not Allowed) Apply for RFA FD 19 021 Funding Number: RFA FD 19 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Novel Approaches to Translational Evidence Generation to Advance Coordinated Registry Networks (CRNs) via Big Data Analytics Using Disparate Data Sources (U01 Clinical Trial Optional) Apply for RFA FD 19 020 Funding Number: RFA FD 19 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF) (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 019 Funding Number: RFA FD 19 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trial Required Apply for RFA FD 19 015 Funding Number: RFA FD 19 015 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $37,500,000 |
| Convener and organizer of activities and engagements focused on the development of medical products and related processes, surveillance, and policies relevant to ongoing public health activities. (U01) Clinical Trial Not Allowed Apply for RFA FD 19 013 Funding Number: RFA FD 19 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,500,000 |
| Renewal Application: Kidney Health Initiative (R18) Clinical Trials Optional Apply for RFA FD 19 016 Funding Number: RFA FD 19 016 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 Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U01) Clinical Trials Not Allowed Apply for RFA FD 19 026 Funding Number: RFA FD 19 026 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Information Sharing System for State-Regulated Drug Compounding Activities (U01) Clinical Trial Not Allowed Apply for RFA FD 19 025 Funding Number: RFA FD 19 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,600,000 |
| Renewal Application: Critical Path Public Private Partnerships (U18) Clinical Trials Optional Apply for RFA FD 19 027 Funding Number: RFA FD 19 027 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $100,000,000 |
| Implementation of U.S. Food Safety Modernization Act - Identifying, Researching, and Implementing Alternative Methods to Expand the Reach across the Global Supply Chain (U01) - Clinical Trials Not Allowed Apply for RFA FD 19 022 Funding Number: RFA FD 19 022 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,750,000 |
| Cigar Tobacco Reference Products Program (UC2) Clinical Trials Not Allowed Apply for RFA FD 20 002 Funding Number: RFA FD 20 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $7,400,000 |
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