[Federal Register: March 9, 2004 (Volume 69, Number 46)]
[Notices]               
[Page 11024]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09mr04-90]                         


[[Page 11024]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. [2004N-0089]

 
Antimicrobial Drug Development; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop, cosponsored with the Infectious Diseases Society of America 
(IDSA) and the International Society of Anti-Infective Pharmacology 
(ISAP), regarding clinical trial design of antimicrobial agents. The 
public workshop is intended to provide information for and gain 
perspectives from advocacy groups, interested health care providers, 
academia, and industry organizations on various aspects of 
antimicrobial drug development, including a discussion of 
microbiological surrogate endpoints in clinical trials to evaluate 
treatments of infectious diseases and issues regarding dose selection 
in the drug development process for antimicrobials. The input from this 
public workshop will help to develop topics for further exploration.
    Date and Time: The public workshop will be held on Thursday, April 
15, 2004, and Friday, April 16, 2004, from 9 a.m. to 5 p.m.
    Location: The public workshop will be held in the Center for Drug 
Evaluation and Research Advisory Committee conference room, 5630 
Fishers Lane, rm. 1066, Rockville, MD. Seating is limited and available 
only on a first-come, first-served basis. Please note there is very 
limited parking in the vicinity of 5630 Fishers Lane, but it is near 
the Twinbrook Metro station. Please bring picture identification in 
order to clear building security.
    Contact Person: John Powers or Leo Chan, Center for Drug Evaluation 
and Research (HFD-104), Food and Drug Administration, 9201 Corporate 
Blvd., Rockville, MD 20850, 301-827-2350.
    Registration: Because seating is limited, we are asking interested 
persons to register on a first-come, first-served basis. To register 
electronically, e-mail registration information (including name, title, 
organization, address, telephone, fax number, and e-mail address) to 
antimicrobial@cder.fda.gov by April 7, 2004. Persons without access to 

the Internet may call 301-827-2350 to register. There is no 
registration fee for the public workshop. Space is limited; therefore, 
interested parties are encouraged to register early.
    Persons needing a sign language interpreter or other special 
accommodations should notify the contact person at least 7 days in 
advance.

SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop, 
cosponsored with IDSA and ISAP, regarding antimicrobial drug 
development. This public workshop will focus on general considerations 
in designing clinical trials for antimicrobial products. Additional 
topics include the utility of microbiological surrogate endpoints in 
clinical trials to evaluate treatments of infectious diseases and 
issues regarding dose selection in the drug development process for 
antimicrobials.
    The agency encourages individuals, patient advocates, industry, 
consumer groups, health care professionals, researchers, and other 
interested persons to attend this public workshop.
    Transcripts: You may request a copy of the transcript in writing 
from the Freedom of Information Staff (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, 
approximately 20 working days after the public workshop at a cost of 10 
cents per page. You may also examine the transcript Monday through 
Friday between 9 a.m. and 4 p.m. in the Division of Dockets Management 
Public Reading Room, Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852, and on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/dockets.htm
.


    Dated: March 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-5191 Filed 3-8-04; 8:45 am]

BILLING CODE 4160-01-S