Document ID: FDA-2010-N-0001-0064
Agency: fda
Document Type: Notice
Title: Antibacterial Resistance and Diagnostic Device and Drug Development Research for Bacterial Diseases; Public Workshop
Posted Date: 2010-06-11T04:00Z

[Federal Register: June 11, 2010 (Volume 75, Number 112)]
[Notices]               
[Page 33317]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jn10-84]                         

[[Page 33317]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

 
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.

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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 
arworkshop@fda.hhs.gov. 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.
[FR Doc. 2010-14048 Filed 6-10-10; 8:45 am]
BILLING CODE 4160-01-S