[Federal Register Volume 76, Number 130 (Thursday, July 7, 2011)]
[Notices]
[Pages 39883-39884]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-16962]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Design of Clinical Trials for Systemic Antibacterial Drugs for
the Treatment of Acute Otitis Media; 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 regarding the design of Clinical Trials for Systemic
Antibacterial Agents for the Treatment of Acute Otitis Media. This
public workshop is intended to provide information for and gain
perspective from health care providers, patients and patient advocacy
organizations, academia, and industry on various aspects of the design
of clinical trials. The input from this public workshop will help in
developing topics for further discussion.
Dates and Times: The public workshop will be held on September 7,
2011 from 8:30 a.m. to 5 p.m.
Location: The public workshop will be held at the Crowne Plaza,
8777 Georgia Ave., Silver Spring, MD 20910, 301-589-0800. Seating is
limited and available only on a first-come, first-served basis.
Contact Persons: Christine Moser or Ramou Mauer, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6193, Silver Spring, MD 20993-0002, 301-
796-1300.
Registration: Registration is free for the public workshop.
Interested parties are encouraged to register early. 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
[email protected]. Persons without access to the Internet may
call 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
regarding scientific considerations in the design of clinical trials of
antibacterial agents for the treatment of acute otitis media (middle
ear infection). Discussions will focus on
[[Page 39884]]
appropriate endpoints for informative clinical trials, the role and
effect of tympanocentesis (drainage of fluid from the middle chamber of
the ear) in clinical trials, and the feasibility and acceptability of
different kinds of clinical trial designs including superiority trial
designs, the data available that might scientifically support feasible
non-inferiority trial designs, and what additional data may be useful
to scientifically support non-inferiority trial designs.
The Agency encourages individuals, patient advocates, industry,
consumer groups, health care professionals, researchers, and other
interested persons to attend this public 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. 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 (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
Transcripts will also be available on the Internet http://www.fda.gov/Drugs/NewsEvents/ucm205809.htm approximately 45 days after the
workshop.
Dated: June 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-16962 Filed 7-6-11; 8:45 am]
BILLING CODE 4160-01-P