Document ID: FDA-2012-N-0001-0136
Agency: fda
Document Type: Notice
Title: Burkholderia; Exploring Current Issues and Identifying Regulatory Science Gaps
Posted Date: 2012-11-07T05:00Z

[Federal Register Volume 77, Number 216 (Wednesday, November 7, 2012)]
[Notices]
[Pages 66850-66851]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27146]

[[Page 66850]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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 on Burkholderia: 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 
by Burkholderia pseudomallei) and glanders (caused by B. 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: http://www.fda.gov/AdvisoryCommittees/default.htm; 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, email: Pamela.Chamberlain@fda.hhs.gov, Web site: http://www.fda.gov/medicalcountermeasures.

SUPPLEMENTARY INFORMATION:

I. Background

    B. pseudomallei is 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. pseudomallei has been determined to pose a 
material threat sufficient to affect the United States' national 
security (Ref. 5).
    B. mallei (formerly Pseudomonas 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 to B. mallei infection has not been studied indepth, the 
organism is highly infectious in the laboratory setting. Prolonged 
antimicrobial therapy is required to treat B. mallei infection and 
prevent its relapse (Refs. 6 and 7). B. mallei has 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 http://www.fda.gov/medicalcountermeasures by 
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 http://www.regulations.gov. (FDA 
has verified the Web site addresses, but we are not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal 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.

[[Page 66851]]

    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: http://www.phe.gov/Preparedness/mcm/phemce/Documents/2012-PHEMCE-Strategy.pdf, 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,'' in Textbook of 
Military Medicine: Medical Aspects of Chemical and Biological 
Warfare (Washington, DC: Office of the Surgeon General, 2007), 
available at: https://ke.army.mil/bordeninstitute/published_volumes/biological_warfare/BW-ch06.pdf, accessed October 16, 2012.

    Dated: November 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27146 Filed 11-6-12; 8:45 am]
BILLING CODE 4160-01-P