Daily Rules, Proposed Rules, and Notices of the Federal Government
Because of the lengthy antibiotic therapy required to treat melioidosis and glanders and the suboptimal clinical outcomes, lack of vaccines, possible biothreat applications, and public health implications, there is significant interest in developing new MCMs as well as improved animal models to evaluate candidate MCMs for these diseases. This public workshop was designed with specific goals that include, but are not limited to:
• Review of the current state of the knowledge of human melioidosis and glanders;
• Discussion of the availability of relevant animal models and their current state of development;
• Discussion of the availability, development, procurement, and stockpiling of relevant MCMs, including diagnostic tests; and
• Identification of the scientific and regulatory considerations associated with testing and development of MCMs for safe and effective treatment or prevention of these diseases.
If you wish to attend the public workshop or view via Webcast, you must register at
There is no fee to register for the public meeting and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.
If you need special accommodations due to a disability, please enter pertinent information in the “Notes” section of the electronic registration form when you register.
The following references have been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at
1. Currie B.J., L. Ward, and A.C. Cheng, “The Epidemiology and Clinical Spectrum of Melioidosis: 540 Cases From the 20 Year Darwin Prospective Study,”
2. Limmathurotsakul D., S. Wongratanacheewin, N. Teerawattanasook, et al, “Increasing Incidence of Human Melioidosis in Northeast Thailand,”
3. Wiersinga W.J., B.J. Currie, and S.J. Peacock, “Melioidosis,”
4. Limmathurotsakul D., W. Chaowagul, W. Chierakul, et al., “Risk Factors for Recurrent Melioidosis in Northeast Thailand,”
5. U.S. Department of Health and Human Services, “2012 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy,” (Washington, DC: U.S. Department of Health and Human Services, 2012), available at:
6. Srinivasan A., “Glanders in a Military Research Microbiologist,”
7. Gregory, B.C., and D.M. Waag, “Glanders,” in