Document ID: FDA-2012-N-0001-0100
Agency: fda
Document Type: Notice
Title: Design of Clinical Trials of Antibacterial Drugs for the Treatment of Non-Cystic Fibrosis Bronchiectasis Public Workshop
Posted Date: 2012-08-16T04:00Z

[Federal Register Volume 77, Number 159 (Thursday, August 16, 2012)]
[Notices]
[Page 49450]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20106]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Issues in the Design of Clinical Trials of Antibacterial Drugs 
for the Treatment of Non-Cystic Fibrosis Bronchiectasis; 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 focusing on the design of clinical trials of antibacterial 
drugs for the treatment of non-cystic fibrosis (non-CF) bronchiectasis. 
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 useful in 
developing topics for further discussion.
    Date and Time: The public workshop will be held on September 7, 
2012, from 8 a.m. to 3:30 p.m.
    Location: The public workshop will be held at the Sheraton Silver 
Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. The hotel's 
phone number is 301-589-0800. Seating is limited and available on a 
first-come, first-served basis.

CONTACT PERSON FOR MORE INFORMATION: Christine Moser or Lori Benner, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 22, rm. 6204, 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, email your registration information (including name, 
title, firm name, address, telephone, and fax number) to 
bronchiectasisworkshop@fda.hhs.gov. Those 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 PERSON FOR MORE 
INFORMATION) at least 7 days in advance.
    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 should 
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/ucm305463.htm) approximately 45 days after 
the workshop.

SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop focusing 
on scientific considerations in the design of clinical trials of 
antibacterial agents for the treatment of non-CF bronchiectasis. 
Discussions will focus on natural history; patient populations for 
enrollment in clinical trials; current standard of care and unmet need; 
clinical trial endpoints, including exacerbation and patient-reported 
outcomes; and clinical trial design elements, including duration of 
treatment and patient followup.
    FDA encourages individuals, patient advocates, industry, consumer 
groups, health care professionals, researchers, and other interested 
persons to attend this public workshop.

    Dated: August 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20106 Filed 8-15-12; 8:45 am]
BILLING CODE 4160-01-P