[Federal Register Volume 63, Number 33 (Thursday, February 19, 1998)]
[Notices]
[Pages 8460-8461]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4078]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Anti-Infective Drugs Advisory Committee Meeting; Amendment of 
Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of meeting of the Anti-Infective Drugs Advisory 
Committee meeting. This meeting was announced in the Federal Register 
of February 3, 1998 (63 FR 5562). The amendment is being made to 
reflect a change in the agenda for the February 19, 1998, meeting day. 
An additional indication for use in the treatment of infections caused 
by Staphylococcus aureus will also be discussed. There are no other 
changes. This amendment will be announced at the beginning of the open 
portion of the meeting.


[[Page 8461]]


FOR FURTHER INFORMATION CONTACT: Ermona B. McGoodwin or Danyiel A. 
D'Antonio, Center for Drug Evaluation and Research (HFD-21), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-
5455, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-
443-0572 in the Washington, DC area), code 12530.
SUPPLEMENTARY INFORMATION: In the Federal Register of February 3, 1998 
(63 FR 5562), FDA announced that a meeting of the Anti-Infective Drugs 
Advisory Committee would be held on February 19 and 20, 1998. This 
amendment is to provide an update to the information provided earlier 
pertaining to the February 19, 1998, meeting day. There are no changes 
for the February 20, 1998, meeting day. On page 5562, in the second 
column, the ``Agenda'' portion is amended to read as follows:
    Agenda: On February 19, 1998, the committee will discuss new drug 
applications 50-747 and 50-748 quinupristin/dalfopristin 
(Synercid, Rhone-Poulenc Rorer Pharmaceuticals, Inc.) for use 
in the treatment of vancomycin-resistant Enterococcus faecium (VREF) 
infections, complicated skin and skin structure infections, community-
acquired pneumonia, hospital-acquired (nosocomial) pneumonia, and 
infections caused by Staphylococcus aureus.

    Dated: February 11, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-4078 Filed 2-18-98; 8:45 am]
BILLING CODE 4160-01-F