[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]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Advisory Committee Meeting; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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]
BILLING CODE 4160-01-F
