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Notice

Design of Clinical Trials for Systemic Antibacterial Drugs for the Treatment of Acute Otitis Media; Public Workshop

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

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.

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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 Start Printed Page 39884appropriate 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.

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Dated: June 30, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2011-16962 Filed 7-6-11; 8:45 am]

BILLING CODE 4160-01-P