
[Federal Register: February 24, 2009 (Volume 74, Number 35)]
[Notices]               
[Page 8265-8266]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24fe09-82]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

 
Clinical Trial Design for Hospital-Acquired Pneumonia and 
Ventilator-Associated Pneumonia; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop, cosponsored with the Infectious Diseases Society of America 
(IDSA), the American College of Chest Physicians (ACCP), the Society of 
Critical Care Medicine (SCCM), and the American Thoracic Society (ATS) 
regarding scientific issues in clinical trial design for hospital-
acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP). 
This public workshop is intended to provide information about, and gain 
perspective from, health care providers, academia, and industry on 
various aspects of antimicrobial drug development for HAP and VAP, 
including diagnosis of HAP and VAP, effect of antimicrobial treatment 
for HAP and VAP, endpoints for trials of HAP and VAP, and statistical 
issues in analysis of results of trials in HAP and VAP. The input from 
this public workshop will help in developing topics for further 
discussion.
    Date and Time: The public workshop will be held on March 31, 2009, 
from 8 a.m. to 6 p.m. and on April 1, 2009, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Crowne Plaza 
Hotel, Kennedy Ballroom, 8777 Georgia Ave., Silver Spring, MD 20910. 
Seating is limited and available only on a first-come, first-served 
basis.
    Contact: 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: To register electronically, e-mail registration 
information (including name, title, firm name, address, telephone, and 
fax numbers) to HAPwkshp@fda.hhs.gov by March 23, 2009. Persons without 
access to the Internet can call 301-796-1300 to register. 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. Persons needing a sign language 
interpreter or other special accommodations should notify Chris Moser 
or Lori Benner (see Contact) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop, 
cosponsored with IDSA, ACCP, SCCM, and ATS, regarding antimicrobial 
drug

[[Page 8266]]

development for HAP and VAP. This public workshop will focus on 
scientific considerations in designing clinical trials for HAP and VAP. 
Topics for discussion include the following: (1) Approaches to the 
diagnosis of HAP and VAP, (2) the effect of antimicrobial treatment for 
HAP and VAP, (3) various endpoints that might be considered as 
endpoints for trials of HAP and VAP, and (4) statistical issues in 
analysis of results from trials in HAP and VAP. The input from this 
public workshop will help in developing topics for further discussion.
    The agency encourages individuals, patient advocates, industry, 
consumer groups, health care professionals, researchers, and other 
interested persons to attend this public workshop.
    Transcripts: Transcripts of the public workshop may be requested in 
writing from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, 
approximately 20 working days after the public workshop at a cost of 10 
cents per page. Transcripts will also be available on the Internet at 
http://www.fda.gov/cder/meeting/hap_vap.htm approximately 45 days 
after the workshop.

    Dated: February 17, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3832 Filed 2-23-09; 8:45 am]

BILLING CODE 4160-01-S
