[Federal Register Volume 72, Number 246 (Wednesday, December 26, 2007)]
[Notices]
[Pages 73028-73029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-24927]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Clinical Trial Design for Community-Acquired Pneumonia; 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, cosponsored with the Infectious Diseases Society of America 
(IDSA), regarding scientific issues in clinical trial design for 
community-acquired pneumonia. This public workshop is intended to 
provide information for and to gain perspective from health care 
providers, academia, and industry on various aspects of antimicrobial 
drug development for community-acquired pneumonia, including diagnosis 
of community-acquired pneumonia, effect of antimicrobial treatment for 
community-acquired pneumonia, endpoints for trials of community-
acquired pneumonia, and statistical issues in analysis of results of 
trials in community-acquired pneumonia. The input from this public 
workshop will help in developing topics for further discussion.
    Date and Time: The public workshop will be held on January 17, 
2008, from 8 a.m. to 6 p.m. and on January 18, 2008, from 8 a.m. to 5 
p.m.
    Location: The public workshop will be held at the Crowne Plaza 
Hotel, Kennedy Room, 8777 Georgia Ave., Silver Spring, MD 20910, 301-
589-0800. Seating is limited and available only on a first-come, first-
served basis.
    Contact Person: Chris Moser or Lori Benner, Center for Drug 
Evaluation and Research, Office of Antimicrobial Products, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6413, 
Silver Spring, MD 20993-0002, 301-796-0767, or 301-796-0849.
    Registration: There is no registration fee for the public workshop. 
Space is limited; therefore, 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 [email protected] by January 9, 2008. Persons without access to 
the Internet can call 301-796-1300 to register. Persons needing a sign 
language interpreter or other special

[[Page 73029]]

accommodations should notify Chris Moser or Lori Benner (see Contact 
Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop, 
cosponsored with IDSA, regarding antimicrobial drug development. This 
public workshop will focus on scientific considerations in designing 
clinical trials for community-acquired pneumonia. The topics for 
discussion include approaches to the diagnosis of community-acquired 
pneumonia, the effect of antimicrobial treatment for community-acquired 
pneumonia, various endpoints that might be considered as endpoints for 
trials of community-acquired pneumonia, and statistical issues in 
analysis of results from trials in community-acquired pneumonia. 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.

    Dated: December 18, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-24927 Filed 12-21-07; 8:45 am]
BILLING CODE 4160-01-S