[Federal Register Volume 60, Number 228 (Tuesday, November 28, 1995)]
[Notices]
[Pages 58630-58631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29084]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: This notice announces a forthcoming meeting of a public
advisory committee of the Food and Drug Administration (FDA). This
notice also summarizes the procedures for the meeting and methods by
which interested persons may participate in open public hearings before
FDA's advisory committees.
FDA has established an Advisory Committee Information Hotline (the
hotline) using a voice-mail telephone system. The hotline provides the
public with access to the most current information on FDA advisory
committee meetings. The advisory committee hotline, which will
disseminate current information and information updates, can be
accessed by dialing 1-800-741-8138 or 301-443-0572. Each advisory
committee is assigned a 5-digit number. This 5-digit number will appear
in each individual notice of meeting. The hotline will enable the
public to obtain information about a particular advisory committee by
using the committee's 5-digit number. Information in the hotline is
preliminary and may change before a meeting is actually held. The
hotline will be updated when such changes are made.
MEETING: The following advisory committee meeting is announced:
Joint Meeting of the Anti-Infective Drugs Advisory Committee and the
Gastrointestinal Drugs Advisory Committee
Date, time, and place. December 13, 1995, 8 a.m., Holiday Inn--
Silver Spring, Plaza Ballroom, 8777 Georgia Ave., Silver Spring, MD.
Type of meeting and contact person. Open committee discussion, 8
a.m. to 5 p.m.; open public hearing, 5 p.m. to 6 p.m., unless public
participation does not last that long; Ermona B. McGoodwin or Valerie
M. Mealy, 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 Hotline, 1-800-741-8138
(301-443-0572 in the Washington, DC area), Anti-Infective Drugs
Advisory Committee, code 12530.-
General function of the committees. The Anti-Infective Drugs
Advisory Committee reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the treatment of infectious diseases and disorders.
The Gastrointestinal Drugs Advisory Committee reviews and evaluates
data on the safety and effectiveness of marketed and investigational
human drugs for use in gastrointestinal diseases.
-Agenda--Open public hearing. Interested persons may present data,
information, or views, orally or in writing, on issues pending before
the committee. Those desiring to make formal presentations should
notify the contact person before December 6, 1995, 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 required to make their comments.
-Open committee discussion. The committees will meet jointly to
discuss data relevant to: (1) Supplemental new drug application (NDA)
50-662/S10 for Biaxin Filmtab (clarithromycin tablets, Abbott
Laboratories), clarithromycin in combination with omeprazole for the
treatment of active duodenal ulcers and prevention of recurrence of
duodenal ulcers associated with Helicobacter pylori; and (2) NDA 20-558
for ranitidine bismuth citrate tablets plus amoxicillin
(Tritec, Glaxo Wellcome, Inc.), and NDA 20-559 for ranitidine
bismuth citrate tablets plus clarithromycin (Tritec, Glaxo
Wellcome, Inc.), for healing and prevention of duodenal ulcer relapse
[[Page 58631]]
due to H. pylori infection when used in conjunction with clarithromycin
or amoxicillin.
FDA public advisory committee meetings may have as many as four
separable portions: (1) An open public hearing, (2) an open committee
discussion, (3) a closed presentation of data, and (4) a closed
committee deliberation. Every advisory committee meeting shall have an
open public hearing portion. Whether or not it also includes any of the
other three portions will depend upon the specific meeting involved.
There are no closed portions for the meetings announced in this notice.
The dates and times reserved for the open portions of each committee
meeting are listed above.
The open public hearing portion of each meeting shall be at least 1
hour long unless public participation does not last that long. It is
emphasized, however, that the 1 hour time limit for an open public
hearing represents a minimum rather than a maximum time for public
participation, and an open public hearing may last for whatever longer
period the committee chairperson determines will facilitate the
committee's work.
Public hearings are subject to FDA's guideline (subpart C of 21 CFR
part 10) concerning the policy and procedures for electronic media
coverage of FDA's public administrative proceedings, including hearings
before public advisory committees under 21 CFR part 14. Under 21 CFR
10.205, representatives of the electronic media may be permitted,
subject to certain limitations, to videotape, film, or otherwise record
FDA's public administrative proceedings, including presentations by
participants.
Meetings of advisory committees shall be conducted, insofar as is
practical, in accordance with the agenda published in this Federal
Register notice. Changes in the agenda will be announced at the
beginning of the open portion of a meeting.
Any interested person who wishes to be assured of the right to make
an oral presentation at the open public hearing portion of a meeting
shall inform the contact person listed above, either orally or in
writing, prior to the meeting. Any person attending the hearing who
does not in advance of the meeting request an opportunity to speak will
be allowed to make an oral presentation at the hearing's conclusion, if
time permits, at the chairperson's discretion.
The agenda, the questions to be addressed by the committee, and a
current list of committee members will be available at the meeting
location on the day of the meeting.
Transcripts of the open portion of the meeting may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857,
approximately 15 working days after the meeting, at a cost of 10 cents
per page. The transcript may be viewed at the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857, approximately 15 working days after the meeting,
between the hours of 9 a.m. and 4 p.m., Monday through Friday. Summary
minutes of the open portion of the meeting may be requested in writing
from the Freedom of Information Office (address above) beginning
approximately 90 days after the meeting.
This notice is issued under section 10(a)(1) and (2) of the Federal
Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR
part 14) on advisory committees.
Dated: November 20, 1995.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 95-29084 Filed 11-28-95; 8:45 am]
BILLING CODE 4160-01-F
