[Federal Register Volume 62, Number 117 (Wednesday, June 18, 1997)]
[Notices]
[Page 33093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15991]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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 Antiviral Drugs Advisory 
Committee. This meeting was announced in the Federal Register of May 
19, 1997. The amendment is being made to add another meeting day, July 
16, 1997, and include another topic for discussion. There are no other 
changes. This amendment will be announced at the beginning of the open 
portion of the meeting.

FOR FURTHER INFORMATION CONTACT: Rhonda W. Stover or John B. Schupp, 
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 12531. Please call the 
Information Line for up-to-date information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 19, 1997 (62 
FR 27261), FDA announced that a meeting of the Antiviral Drugs Advisory 
Committee would be held on July 14 and 15, 1997.
    On page 27261, beginning in the third column, the ``Date and Time'' 
and the ``Agenda'' portions for the Antiviral Drugs Advisory Committee 
meeting are amended as follows:
    Date and Time: The meeting will be held on July 14, 15, and 16, 
1997, 8:30 a.m. to 5 p.m.
    Agenda: On July 14 and 15, 1997, the committee will discuss the 
utility of plasma human immunodeficiency virus (HIV) RNA measurement as 
an endpoint in clinical trials for drugs to treat HIV infection. In 
light of the rapid changes in knowledge about the pathophysiology of 
HIV infection, the advances in the technologies to quantify HIV in 
plasma, and the evolution of antiviral therapy, FDA is soliciting 
opinions and advice from the advisory committee on this topic. On July 
16, 1997, the committee will discuss data relevant to new drug 
application (NDA) 50-740, AmBisome (liposomal amphotericin B, 
Fujisawa, USA), as empirical therapy for presumed fungal infection in 
febrile neutropenic patients.

    Dated: June 12, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-15991 Filed 6-17-97; 8:45 am]
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