2010-14048. Antibacterial Resistance and Diagnostic Device and Drug Development Research for Bacterial Diseases; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a public workshop jointly sponsored by the National Institute of Allergy and Infectious Diseases and the Infectious Diseases Society of America (IDSA) regarding scientific and potential research issues in antibacterial drug resistance, rapid diagnostic device development for bacterial diseases, and antibacterial drug development. The workshop will address antibacterial drug resistance, mechanisms of resistance, epidemiology of resistance, and issues in the development of rapid diagnostic devices and antibacterial drugs for the diagnosis and treatment of bacterial diseases. The input from this public workshop will help in developing topics for further discussion.

Dates and Times: The public workshop will be held on July 26, 2010, from 8 a.m. to 5:30 p.m. and on July 27, 2010, from 8 a.m. to 5 p.m.

Location: The public workshop will be held at the Crowne Plaza Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. Seating is limited and available only on a first-come, first-served basis.

Contact Persons: Chris Moser or Lori Benner, Center for Drug Evaluation and Research, Food and Drug Administration, Office of Antimicrobial Products, 10903 New Hampshire Ave., Bldg. 22, rm. 6209, Silver Spring, MD 20993-0002, 301-796-1300.

Registration: Registration is free for the public workshop. Interested parties are encouraged to register early because space is limited. Seating will be available on a first-come, first-served basis. To register electronically, e-mail registration information (including name, title, firm name, address, telephone, and fax number) to [e-mail]. Persons without access to the Internet can call Chris Moser or Lori Benner at 301-796-1300 to register. Persons needing a sign language interpreter or other special accommodations should notify Christine Moser or Lori Benner (see Contact Persons) at least 7 days in advance.

SUPPLEMENTARY INFORMATION:

FDA is announcing a public workshop, jointly sponsored by the National Institute of Allergy and Infectious Diseases and the Infectious Diseases Society of America, regarding scientific issues in antibacterial drug resistance and product development for bacterial diseases. Topics for discussion include the following: (1) An overview and discussion of the scale of the current bacterial resistance problem, (2) current understanding of the science and mechanisms of bacterial resistance, (3) the use of rapid diagnostics in the diagnosis and management of bacterial infections, and (4) the science of antibacterial drug development. The input from this workshop will help in the further consideration of potential areas of research in antibacterial resistance and help in developing topics in antibacterial drug development and rapid diagnostic development for further discussion.

The agency encourages individuals, patient advocates, industry, consumer groups, health care professionals, researchers, and other interested persons to attend this public workshop.

Webcasting: The workshop will be simultaneously webcast. The public may view the live webcast free by registering through IDSA's Web site at http://www.idsociety.org until 24 hours prior to the workshop. IDSA will do its best to accommodate members of the public who register after this time. Videotaped workshop presentations will also be available free on IDSA's Web site following the workshop.

Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI-35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857. Transcripts will also be available on the Internet at http://www.fda.gov/​FDAgov/​Drugs/​NewsEvents/​ucm211146.htm approximately 45 days after the workshop.

Dated: June 7, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.