Daily Rules, Proposed Rules, and Notices of the Federal Government


Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Public Workshop on Burkholderia: Exploring Current Issues and Identifying Regulatory Science Gaps

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
SUMMARY: The Food and Drug Administration (FDA) is announcing the following meeting: "Public Workshop onBurkholderia:Exploring Current Issues and Identifying Regulatory Science Gaps." An interagency planning committee led by FDA, in collaboration with the Defense Threat Reduction Agency; the National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health; the Centers for Disease Control and Prevention; the U.S. Army Medical Research Institute of Infectious Diseases; the Biomedical Advanced Research and Development Authority; the Chemical Biological Medical Systems Joint Project Management Office; the U.S. Strategic Command Center for Combating Weapons of Mass Destruction; and the Joint Science and Technology Office for Chemical and Biological Defense, developed this workshop to present the most current information on melioidosis (caused byBurkholderia pseudomallei) and glanders (caused byB. mallei), with the general purpose of building on information presented at previous meetings and identifying future areas of research needed to advance animal model development and to advance candidate medical countermeasures (MCMs) for approval, licensure, or clearance.
DATES: This public workshop will be held on Thursday, November 29, 2012, from 8 a.m. EST to 5 p.m. EST, and Friday, November 30, 2012, from 8 a.m. EST to 12 noon EST. Persons interested in attending the workshop in person or viewing via Webcast must register by Wednesday, November 21, 2012, at 5 p.m. EST.
ADDRESSES: The public workshop will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993-0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:;under the heading "Resources for You," click on "Public Meetings at the FDA White Oak Campus." Please note that visitors to the White Oak Campus must enter through Building 1.
FOR FURTHER INFORMATION CONTACT: Pamela Chamberlain, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4122, 301-796-2968, FAX: 301-847-8615,,Web site:

B. pseudomalleiis a gram-negative bacterial pathogen that causes melioidosis, a disease endemic in Southeast Asia and northern Australia. Melioidosis is historically associated with a high mortality rate due to the speed with which septicemia develops and the inherent resistance of the bacteria to several classes of antibiotics. For example, a 20-year prospective study of melioidosis in northern Australia found an overall mortality of 14 percent and a 50 percent mortality rate for patients with septic shock (Ref. 1). A 9-year prospective study of melioidosis in northeast Thailand found an overall mortality rate of 42.6 percent (Ref. 2). Prolonged courses of antibiotics are required to treat melioidosis (Ref. 3). Despite prolonged antimicrobial therapy, recurrent disease is common (at a rate of greater than or equal to 6 percent in the first year) (Refs. 1 and 4). In addition to the public health threat posed by naturally occurring infections,B. pseudomalleihas been determined to pose a material threat sufficient to affect the United States' national security (Ref. 5).

B. mallei(formerlyPseudomonas mallei) is a gram-negative, bacterial pathogen that causes glanders and is primarily a zoonotic disease in Africa, Asia, the Middle East, and Central/South America. Natural glanders infections occur primarily in horses, donkeys, and mules, but most mammals have some degree of susceptibility. While human susceptibility toB. malleiinfection has not been studied indepth, the organism is highly infectious in the laboratory setting. Prolonged antimicrobial therapy is required to treatB. malleiinfection and prevent its relapse (Refs. 6 and 7).B. malleihas also been determined to pose a material threat sufficient to affect the United States' national security (Ref. 5).

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.

II. How to Register

If you wish to attend the public workshop or view via Webcast, you must register at Wednesday, November 21, 2012, at 5 p.m. EST. When registering, you must provide the following information: (1) Your name, (2) title, (3) company or organization (if applicable), (4) mailing address, (5) phone number, and (6) email address.

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.

III. References

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 has verified the Web site addresses, but we are not responsible for any subsequent changes to the Web sites after this document publishes in theFederal Register.)

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,”Public Library of Science Neglected Tropical Diseases,vol. 4(11):e900, 2010.

2. Limmathurotsakul D., S. Wongratanacheewin, N. Teerawattanasook, et al, “Increasing Incidence of Human Melioidosis in Northeast Thailand,”American Journal of Tropical Medicine and Hygiene,vol. 82(6), pp. 1113-1117, 2010.

3. Wiersinga W.J., B.J. Currie, and S.J. Peacock, “Melioidosis,”The New England Journal of Medicine,vol. 367(11), pp. 1035-1044, 2012.

4. Limmathurotsakul D., W. Chaowagul, W. Chierakul, et al., “Risk Factors for Recurrent Melioidosis in Northeast Thailand,”Clinical Infectious Diseases,vol. 43(8), pp. 979-986, 2006.

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:,accessed October 16, 2012.

6. Srinivasan A., “Glanders in a Military Research Microbiologist,”The New England Journal of Medicine,vol. 345(4), pp. 256-258, 2001.

7. Gregory, B.C., and D.M. Waag, “Glanders,” inTextbook of Military Medicine: Medical Aspects of Chemical and Biological Warfare(Washington, DC: Office of the Surgeon General, 2007), available at:,accessed October 16, 2012.

Dated: November 1, 2012. Leslie Kux, Assistant Commissioner for Policy.