[Federal Register Volume 63, Number 75 (Monday, April 20, 1998)]
[Notices]
[Page 19501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-10311]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Antiviral Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Antiviral Drugs Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA regulatory issues.
    Date and Time: The meeting will be held on May 4, 1998, 8:30 a.m to 
5 p.m.; on May 5, 1998, 8 a.m. to 5 p.m.; and on May 6, 1998, 7:30 a.m. 
to 5 p.m.
    Location: Gaithersburg Hilton, Ballroom, 620 Perry Pkwy., 
Gaithersburg, MD.
    Contact Person: 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.
    Agenda: On May 4, 1998, the committee will discuss new drug 
application (NDA) 20-903, Intron<Register>A/Rebetol, (interferon alfa-
2b, recombinant/ribavirin, Schering Corp.) for the treatment of chronic 
hepatitis C. On May 5, 1998, the committee will discuss NDA 50-752, 
Priftin<Register> (rifapentine, Hoechst Marion Roussel, Inc.) for the 
treatment of pulmonary tuberculosis. On May 6, 1998, the committee will 
discuss NDA 20-871, NTZ<SUP>TM</SUP> (nitazoxanide, UNIMED 
Pharmaceuticals, Inc.) for the treatment of diarrhea associated with 
cryptosporidiosis in acquired immune deficiency syndrome (AIDS) 
patients.
    Procedure: On May 4, 1998, from 8:30 a.m. to 5 p.m.; on May 5, 
1998, from 8 a.m. to 10:30 a.m. and from 12 m. to 5 p.m.; and on May 6, 
1998, from 9 a.m. to 5 p.m., the meeting is open to the public. 
Interested persons may present data, information, or views, orally or 
in writing, on issues pending before the committee. Written submissions 
may be made to the contact person by April 27, 1998. Oral presentations 
from the public will be scheduled between approximately 11 a.m. and 12 
m. on May 4 and May 6, 1998. On May 5, 1998, oral presentations from 
the public will be scheduled between approximately 1 p.m. and 2 p.m. 
Time allotted for each presentation may be limited. Those desiring to 
make formal oral presentations should notify the contact person before 
April 27, 1998, and submit a brief statement of the general nature of 
the evidence or arguments they wish to present, the names and addresses 
of proposed participants, and an indication of the approximate time 
requested to make their presentation.
    Closed Committee Deliberations: On May 5, 1998, from 10:30 a.m. to 
12 m., the meeting will be closed for a presentation of confidential 
material (5 U.S.C. 552(b)(2) and (b)(5)). On May 6, 1998, from 7:30 
a.m. to 9 a.m., the meeting will be closed to permit discussion and 
review of trade secret and/or confidential information (5 U.S.C. 
552(b)(4)). The selected NDA's will be discussed.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: April 14, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-10311 Filed 4-17-98; 8:45 am]
BILLING CODE 4160-01-F