Antibacterial 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 National Action Plan outlines steps for implementing the National Strategy for Combating Antibiotic-Resistant Bacteria to address urgent and serious drug-resistant threats that affect people in the U.S. and around the world. 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.
Opportunities for Collaboration
- 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
- Request for Proposals: Research Funding Opportunity to Facilitate the Development or Refinement of Rabbit Animal Models of Ventilator-Associated Bacterial Pneumonia (Research Priority Area 2.4.2) - Open.
- Request for Proposals: Research Funding Opportunity to Facilitate Updating Susceptibility Test Interpretive Criteria (Breakpoints) (Research Priority Area 2.4.4) - Open.
- Grant Announcement:: Title: Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01) - Closed
- FY 2019 Request for Information “Development of New Antibacterial Drugs Active Against Multi-Drug Resistant Bacteria" Closed
- FY 2017 Request for Information (RFI) on the development of animal models of infection Closed
- Additional Information for Offerors Concerning Research Funding Opportunities through the FDA Broad Agency Announcement (FDABAA-17-00123N) to Facilitate Antibacterial Drug Development and Address Antibacterial Drug Resistance (PDF - 179KB) Closed
- FDA Antibacterial Drug Resistance Fellowship - OPEN
- Application Deadline: 9/30/2020
- FDA Antibacterial Drug Resistance Micro-Epidemiology Fellowship - OPEN
- Application Deadline 9/30/2020
- Advancing Animal Models for Antibacterial Drug Development (March 5, 2020)
- Current State and Further Development of Animal Models of Serious Infections Caused by Acinetobacter baumannii and Pseudomonas aeruginosa (March 1, 2017)