Document ID: FDA-2010-N-0001-0082
Agency: fda
Document Type: Notice
Title: Design of Clinical Trials of Aerosolized Antimicrobials for Treatment of Cystic Fibrosis; Public Workshops
Posted Date: 2010-08-03T04:00Z

[Federal Register: August 3, 2010 (Volume 75, Number 148)]
[Notices]               
[Page 45646-45647]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03au10-81]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Design of Clinical Trials of Aerosolized Antimicrobials for the 
Treatment of Cystic Fibrosis; 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 scientific issues in clinical development of 
aerosolized antimicrobials for the management and/or treatment of 
patients with cystic fibrosis. Aerosolized antimicrobials are used to 
treat chronic bacterial infection in the lungs and thus improve the 
respiratory symptoms in patients with cystic fibrosis. 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 of aerosolized antimicrobials in patients with 
cystic fibrosis. 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 23, 
2010, from 8:30 a.m. to 5:30 p.m. and on September 24, 2010, from 8 
a.m. to 4 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 
CFWORKSHOP@fda.hhs.gov Persons without access to the Internet can 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 
aerosolized antimicrobials to treat chronic bacterial infection in the 
lungs and thus improve the respiratory symptoms in patients with cystic 
fibrosis. The development of clinical trial endpoints to establish 
efficacy is a major challenge in the design of informative clinical 
trials of aerosolized antimicrobials for the management and/or 
treatment of patients with cystic fibrosis. The workshop will include 
discussion of clinical trial endpoints to establish efficacy, such as 
timing and definitions of pulmonary exacerbations, changes in the 
results of pulmonary function testing, and changes on patient reported 
outcome measures. An important consideration will be the evaluation of 
new aerosolized antimicrobials in the context of approved aerosolized 
antimicrobials on the basis of these or other efficacy endpoints. Other 
issues in the design of clinical trials of aerosolized antimicrobials 
include: The development of drug resistance and

[[Page 45647]]

other safety concerns, microbiologic testing such as sputum bacterial 
density, the utility of in-vitro susceptibility testing, and the need 
for pediatric use information.
    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 (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 http://www.fda.gov/Drugs/NewsEvents/ucm205809.htm 
approximately 45 days after the workshop.

    Dated: July 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19044 Filed 8-2-10; 8:45 am]
BILLING CODE 4160-01-S