[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