Meetings: Antiviral Drugs Advisory Committee,
FR, September 10, 1999 › Notices › Food and Drug Administration
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Federal Register: September 10, 1999 (Volume 64, Number 175)NoticesPage 49192From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr10se99-116
[Page 49192]
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.
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's regulatory issues.
Date and Time: The meeting will be held on October 4, 1999, 8 a.m. to 5 p.m., and on October 5, 1999, 8 a.m. to 12 m.
Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., 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, 301-827-7001, 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 October 4, 1999, presentations and committee discussions will address issues related to the potential applicability of information from non-U.S. studies of prevention of perinatal human immunodeficiency virus transmission to U.S. clinical settings.
Procedure: 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 September 27, 1999. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on October 4, 1999. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before September 27, 1999, 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 October 4, 1999, from 2 p.m to 5 p.m., and on October 5, 1999, from 8 a.m. to 12 m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information relevant to pending investigational new drug applications and drug development plans (5 U.S.C. 552b(c)(4)). Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Dated: September 2, 1999. Linda A. Suydam, Senior Associate Commissioner.
FR Doc. 99-23465Filed9-9-99; 8:45 amBILLING CODE 4160-01-F
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