Office of Infectious Diseases Research Activities
Antimicrobial Regulatory Science Research
Antimicrobial drug resistance is a major threat to public health. In March 2015, The National Action Plan for Combating Antibiotic-resistant Bacteria was developed in response to Executive Order 13676: Combating Antibiotic-Resistant Bacteria, which was issued on September 18, 2014. The updated National Action Plan for 2020 -2025 continues to outline steps for implementing the National Strategy for Combating Antibiotic-Resistant Bacteria to address urgent and serious drug-resistant threats (bacteria and fungi) that affect people in the U.S. and around the world. The updated Plan follows the framework of CDC’s 2019 AR Threats Report and uses the term “antibiotic” to describe antibacterial and antifungal drugs, which kill bacteria and fungi, respectively. Implementation of the National Action Plan will also support World Health Assembly resolution 67.25 (Antimicrobial Resistance), which urges countries to take urgent action at the national, regional, and local levels to combat resistance.
The FDA’s roles in combatting antibacterial drug resistance include:
- Facilitating the development of new antibacterial drugs to treat patients; and
- Advancing the science of clinical trial design. The design and conduct of clinical trials to evaluate new antibacterial drugs in patients with serious bacterial infections is challenging and therefore of particular interest for FDA’s regulatory science program.
What’s New
- FY 2016 - FY 2021 Office of Infectious Diseases CARB Research Overview (PDF - 370 KB)
- CDER Impact Story: Exploiting Real-World Data to Optimize the Use of Antibiotics
Background
Current Funding Opportunities
- The FDA currently has an open announcement under the FDA’s Broad Agency Announcements for the Advanced Research and Development of Regulatory Science. This is a competitive announcement where research proposals to facilitate antibacterial drug development and address antibacterial drug resistance are evaluated on an ongoing basis throughout the fiscal year.
Open, Quad Charts & White Papers Due 1/21/2022.- Request for Proposals: Research Funding Opportunity to Facilitate Updating Susceptibility Test Interpretive Criteria (Breakpoints) (Research Priority Area 2.4.4) Open
- Request for Proposals: Research Funding Opportunity to Facilitate Development of Urine-Specific Susceptibility Test Interpretive Criteria (Breakpoints) (Priority Area 2.4.4) Open
- Request for Proposals: Research Funding Opportunity to Develop Patient Reported Outcome Tools for Use in Allergic Bronchopulmonary Aspergillosis (ABPA) (Research Priority Area 2.4.1) Open
- Request for Proposals: Research Funding Opportunity to Optimize Dosing Strategies for Antimicrobial Drugs (Research Priority Area 2.4.2) Open
ORISE Fellowship Opportunities
Public Meetings
- CDER SBIA Webinar - Office of New Drugs (OND) Research: Seeking Collaborators, Funding Opportunities Available (November 6, 2020)
- Addressing Challenges in Inhaled Antifungal Drug Development (September 25, 2020)
- Coccidioidomycosis (Valley Fever): Considerations for Development of Antifungal Drugs (August 5, 2020)
- Advancing Animal Models for Antibacterial Drug Development (March 5, 2020)
- Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease (April 18, 2019)
- Development of Inhaled Antibacterial Drugs for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis (June 27, 2018)
- Current State and Further Development of Animal Models of Serious Infections Caused by Acinetobacter baumannii and Pseudomonas aeruginosa (March 1, 2017)