
[Federal Register Volume 76, Number 130 (Thursday, July 7, 2011)]
[Notices]
[Pages 39883-39884]
From the Federal Register Online via the Government Printing 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 

Otitisworkshop@fda.hhs.gov. 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




