[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, IntronA/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 (rifapentine, Hoechst Marion Roussel, Inc.) for the
treatment of pulmonary tuberculosis. On May 6, 1998, the committee will
discuss NDA 20-871, NTZTM (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