Intramural Regulatory Science Programs
ORES funds research by internal staff to advance the regulatory mission and promote public health.
The Office of Regulatory and Emerging Science (ORES) manages three FDA programs that provide funding to support intramural regulatory science and innovation to address scientific and public health priorities. Our goal is to advance discovery and innovation in regulatory science to help translate cutting-edge science and technology into safe and effective medical products.
ORES’s role is to coordinate the review and granting of competitive intramural research awards under the following research areas:
- Medical Countermeasures (MCMs) - to help translate cutting-edge science and technology into safe and effective MCMs needed to respond to chemical, biological, radiological, nuclear threats and emerging infectious diseases.
- Minority Health and Health Equity - to advance minority health and health equity, the understanding of health disparities, and to provide future directions for research that contributes to regulatory decision making.
- Cross-Agency Regulatory Science (CARS) - to advance innovative research that shows strong promise in addressing major regulatory science needs that will advance FDA’s regulatory mission and public health.
Leadership and funding for the Minority Health and Health Equity Intramural Regulatory Science Challenge Grant Program are provided by the Office of Minority Health & Health Equity.
Leadership and funding for the MCM and CARS Intramural Regulatory Science Challenge Grant Programs are provided by ORES.
Cross-Agency Regulatory Science (CARS) Intramural Regulatory Science Challenge Grant Program
ORES provides funding to support innovative intramural regulatory science research that shows strong promise in addressing major regulatory science needs that will advance FDA’s regulatory mission and public health.
ORES prioritizes intramural research projects that demonstrate cross-agency collaboration, exceptional and innovative ideas to advance regulatory science, broad impact for more than one FDA office, excellent scientific merit to further regulatory science efforts of other stakeholders, and have a practical application and the potential for regulatory impact. Additional consideration is given to proposals that address Alternative Methods, One Health, or Nanotechnology.
| Project | Awardee | Lead Center | Collaborators |
|---|---|---|---|
| Development of a novel pathogen reduction technology (PRT) for stored human whole blood as an alternative to current PRTs available or in the pipeline | Atreya, Chintamani D. | CBER | NCTR |
| Rapid Confirmation of Microbial Isolates Using Whole Genome Sequencing | Neal-McKinney, Jason | ORA | OCS |
| Advancing Quality and Safety Assessment of Synthetic Oligonucleotides with Emerging Precision Analytics and New Alternative In-Vitro Methods Aided by Machine Learning for Improved Predictability | Yang, Kui | CDER | NCTR |
| Uncertainty Quantification in AI-enabled Classification Models | Cao, Qian | CDRH | CVM, CDC |
| Design and Optimization of Analytical Methods for Handheld and Field Portable Devices to Detect Active Pharmaceutical Ingredients (APIs) in FDA-Regulated Products at Remote Sampling Sites | Kimani, Martin | ORA | CDER |
| AnimalGAN: A Generative Artificial Intelligence Model Complementary to Animal Studies | Tong, Weida | NCTR | Welch, Lacinda |
| Chemical Contaminants in Soil -Assessing Uptake and Bioaccumulation in Fresh Produce and Subsequent Impact on Human Health | Trujillo, Socrates | CFSAN | OCS, OSTP, NIH |
| One Health AMR Monitoring: Standardizing the detection and reporting of critically important antimicrobial resistance (AMR) | Andrea Ottesen | CVM | |
| Development of An Analysis Pipeline for the Assessment of Reference Databases Used in Microbial Metagenomic Analysis Software | David Erickson | CDRH | |
| Assessing and mitigating the bias in applying Artificial Intelligence (AI) based natural language processing (NLP) of drug labeling documents | Leihong Wu | NCTR | Welch, Lacinda |
| Synthesis and Characterization of a Newly Identified Arsenic Species Present in Rice Grain | Kevin Kubachka | ORA | |
| Development of Specific and Sensitive Diagnostic Devices for Emergent Flaviviruses | Maria Rios | CBER | |
| Active safety surveillance of cannabis-derived products using electronic health record (EHR) data | Silvia Perez Vilar | CDER |
Resources For You
- Intramural Grant Programs | FDA
- Intramural Research | FDA
- Focus Areas of Regulatory Science - Approach | FDA
Contact the Office of Regulatory and Emerging Science: ORES@fda.hhs.gov.