E9-3832. 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 [e-mail] 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 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.