[Federal Register Volume 68, Number 151 (Wednesday, August 6, 2003)]
[Notices]
[Page 46647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20064]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Food and Drug Administration and National Institute of Allergy 
and Infectious Diseases; 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 National Institute of Allergy and 
Infectious Diseases (NIAID), regarding clinical trial design of febrile 
neutropenia and antifungal combination therapy. 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 febrile neutropenic and antifungal 
drug development.

DATES: The public workshop will be held on Thursday, September 4, 2003, 
from 1 p.m. to 5 p.m.

ADDRESSES: The public meeting will be held at the Hyatt Regency 
Bethesda, One Bethesda Metro Center, Bethesda, MD 20814. Seating is 
limited and available on a first-come, first-served basis. See the 
SUPPLEMENTARY INFORMATION section for information on electronic 
registration.

FOR FURTHER INFORMATION CONTACT: John Powers or Leo Chan, Center for 
Drug Evaluation and Research (HFD-104), Food and Drug Administration, 
9201 Corporate Blvd., Rockville, MD 20850, (301) 827-2530.

SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop, 
cosponsored with NIAID, regarding two drug development scenarios: (1) 
Studies of empirical therapy in febrile neutropenic patients; and (2) 
clinical trial design considerations necessary to adequately determine 
safety and efficacy of antifungal combination therapies. Both agencies 
encourage individuals, patient advocates, industry, consumer groups, 
health care professionals, researchers, and other interested persons to 
attend this public workshop. The input from this public workshop will 
be used to develop topics for discussion at future meetings of the 
Antiviral Drugs Advisory Committee.
    Because seating is limited, we are asking interested persons to 
register on a first-come, first-served basis. To register 
electronically, go to FDA's Web site at http://www.fda.gov/cder/drug/antimicrobial/default.htm. Those without access to the Internet can 
call (301) 827-2530 to register.

    Dated: July 30, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-20064 Filed 8-5-03; 8:45 am]
BILLING CODE 4160-01-S